Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1924066

FEI Number

1924066

Entity Name

Allied Medical LLC

City/State/Country

Earth City, MO, US

Establishment Address

13622 Lakefront Dr, Earth City, MO 63045, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Allied Medical LLC (Owner Number: 9919025)

Owner / Operator Contact Address

13622 Lakefront Drive, Earth City, MO 63045, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K812624

PMA Number

N/A

All Registered Proprietary Names

AUTOVENT 4000 Mouth Prop Lif-O-Gen / Allied Emergency oxygen Kit Formerly TXO2 Lif-O-Gen Emergency Oxygen Kit, Allied Healthcare Products Inc. Emergency Oxygen Kit CAM 4 OXYGEN CANOPY CAMTENT, ELECTRICALLY POWERED CANOPIES PMX BAG MASK RESUSCITATOR IMV RESPICAL CALIBRATION ANALYZER Airdyne Air Compressor Gomco Circumcision Clamp EPV200 VENTILATOR OXYGEN CATHETER BURN SHEET AND TOWELS LSP AUTOVENT 3000 AHP300 Ventilator FACE MASK OXYGEN MASKS AEROSOL LSP TRU-FIT MASK LSP 554 BAG MASK RESUSCITATOR Schuco Suction Pumps Various TIMETER OXYGEN CONCENTRATOR AIR PANTS Schuco Air Compressor, Allied Air Compressor, EMG Technology VARIOUS INTERMITTENT TIMETER - VACCUM REGULATORS Infant Bag Mask Resuscitator Allied, Life Support Products (LSP), XTRA, HDX, Spine-X, Stablizer, Life-Lite BREATHING MOUTHPIECE MOUTHPIECE WITH FLEX TUBE CANNULA 4 FT TUBING ANSAL NASAL CANNULA DISPOSABLE COLLECTION UNIT (DCU) MISTOGEN PCS-5 Air Compressor Accessories ASSEMBLIES ; HOSES ADAPTERS CONDUCTIVE HOSE Various Timeter Air Compressors B AND F VENTURI MASK Omni Vent Series D Ventilator B&F Medical B AND F OXYGEN NON REBREATHING MASK GOMCO PUMPS Autovent 2000 Allied, Timeter Pulse oximeter GOMCO PUMPS SCHUCO REFRACTOMETERS Schuco Model S3000 LSP INFANT DISPOSABLE BAG MASK RESU Schuco S4000 and S4200 Nebulizer Suction Regulators Various Schuco Pump Aspiration B AND F WATER TRAP LSP Demand Valves GOMCO Automatic Ventilator GOMCO HUMIDIFIER/NEBULIZER LSP 502 Resuscitatory Inhalator Val MCV-AUXBAT, BATTERY PACK LSP AUTOVENT 2000 Liberty Oxygen Conserver P.E.E.P. Valve Omni Vent D/MRI Ventilator Emergency Oxygen Kit / Case GOMCO SUCTION ETHER PUMPS Portable Oxygen Unit CPR-L770 RESUSCITATION TIMER LIFE + LITE STRETCHER Portable Resuscitator Kits resuscitimer Schuco Nebulizer Allied Healthcare Products Inc., AHP300P Ventilator TIMETER - REGULATOR OXYGEN THERAPY LSP DISPOSAL BAG MASK RESUSCITATOR OXYGEN THERAPY REGULATOR LSP OXYGEN REGULATOR WITH CONSTANT ALSO LSP OXYGEN REGULATOR. STAGE(SINGLE GEN REGULATOR. TWO) THERAPY TIMETER RT200 EPV100 Ventilator TIMETER RT200 OXEQUIP TIMETER FLOWMETERS MCV200 AND MCV200-B VENTILATOR Schuco Pumps Nebulizer Schuco Vac Model 178, G180,L190 MCV100 & MCV100-B Ventilators FIRST AID SPLINT NOSE CLIP Nebulizer Disposable Bag Mask Resuscitator GOMCO OXYGEN TIMER LSP Minilator Oxequip Breathing Circuit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-01-02
JXL	Block, Bite	Neurology	Class 2	882.5070	2008-03-31
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2012-12-06
BYK	Tent, Oxygen, Electrically Powered	Anesthesiology	Class 2	868.5710	2008-01-02
BYL	Tent, Oxygen	Anesthesiology	Class 1	868.5700	1992-12-14
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-01-02
CBO	Attachment, Intermittent Mandatory Ventilation (Imv)	Anesthesiology	Class 2	868.5955	2008-03-31
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	1992-12-14
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2008-03-31
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2008-03-31
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2009-05-26
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	1992-12-14
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2001-08-22
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-01-02
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2014-04-08
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	1992-12-14
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-01-02
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2009-09-17
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2008-01-02
LHX	Trousers, Anti-Shock	Cardiovascular	Class 2	870.5800	2006-09-11
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2012-12-06
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	1992-12-14
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-02-18
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	1998-03-19
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2001-08-22
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	1992-12-14
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	1992-12-14
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	1992-12-14
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2008-02-19
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	1992-12-14
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2008-03-31
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2001-08-22
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2008-02-18
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2014-10-30
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2001-08-22
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	1992-12-14
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-02-18
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2008-03-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-02-18
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2008-01-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2008-05-28
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2008-02-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-01-02
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2008-02-18
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	1994-01-31
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2008-02-18
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2001-08-22
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-02-18
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	1992-12-14
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-02-18
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1992-12-14
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-03-31
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-02-19
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2009-05-26
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-01-02
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2008-02-18
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2008-02-18
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2008-02-18
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2008-02-19
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	1992-12-14
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2008-02-19
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2001-06-08
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2001-08-22
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-03-31
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-02-18
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-02-18
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2014-05-12
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	1992-12-14
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-01-02
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	1992-12-14
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	1992-12-14
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-03-31
BXX	Calibrator, Pressure, Gas	Anesthesiology	Class 1	868.2620	1992-12-14
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	1992-12-14
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2009-05-26
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2008-03-31
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2008-03-31
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2008-02-18
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-08-19
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2006-03-27
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2001-08-22
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2008-02-19
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-02-18
JPW	Pump, Nebulizer, Electrically Powered	Ear, Nose, Throat	Class 1	874.5220	1992-12-14
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2008-03-31
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2008-02-19
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2008-02-19

Official Correspondent

Khashayar Poormand

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Allied Medical LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1314798	Allied Medical LLC	STUYVESANT FALLS, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26
K082762	Aardvark Medical	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	2008-11-12
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.

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8044169	PLAXTRON INDUSTRIAL (M) SDN. BHD.	IPOH Perak, MY
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1924066. Last updated year: 2026. Please use registration number 1924066 when referencing this establishment in official correspondence.