Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518436

FEI Number

2518436

Entity Name

INSTRUMENTATION INDUSTRIES, INCORPORATED

City/State/Country

BETHEL PARK, PA, US

Establishment Address

2990 INDUSTRIAL BLVD, BETHEL PARK, PA 15102, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

INSTRUMENTATION INDUSTRIES, INCORPORATED (Owner Number: 2518436)

Owner / Operator Contact Address

2990 INDUSTRIAL BLVD., Bethel Park, PA 15102, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RTC 24-V MDI Adapter RTC 24-V Kit MDI Adapter Kit RTC 21-A RTC 21-D Metered Dose Inhalers BE 30-115-BL BE 30-115-B NS 30-115-5 NS 30-115-UL NS 30-115-U NS 30-115-5L SG 066-2N Single-Use Breathing Bag SG 066 Oxygen Enrichment Kit ACU 1060.2 ACU 1060.1 NS Series NIF Meters NIF Meter Adapters and accessories BE 409 Pilot Tube Repair Kit CB 23-1 BE 105-40 SH 7-2 BE 167 MS 101-40 SC 603-A KC 5 BE 169 KC 145-2230D NP 130-22 BE 168 BE 145-2230P SH 74 Series Swivel Barbed Tubing Adapters CB 23 ADP 150 KC 145-1522D BE 145-2P KC 6PA SH 75 Series Swivel Barbed Tubing Adapters BE 145-1522P BE 105-101-40 BE 139 SR 75 Series KC 003N BE 150-5G KC 003N-2P BE 150-5LF KC 002N KC 002N-2P SG 066-2N-2P KC 00.5N-2P KC 00.5N EM 001-N SG 066-2N NOSE CLIP RTC 24-VP BE 3000-FA Instant Flow Valve BE 3000-RA Instant Flow Valve BE 3000-PA Instant Flow Valve BE 3000-FS Instant Flow Valve BE 3000-PS Instant Flow Valve BE 3000-WM Wall Mount for Instant Flow Valve BE 3000-RS Instant Flow Valve Gauge Clamps and accessories NS Series Airway Pressure Monitors NS Series Cuff Pressure Monitors WT 125 Water Trap WT 250 Water Trap HG 100 Humidifier Guard KC XXX-5P Tubing KC XXX-19R Tubing KC XXX-5 Tubing KC XXX-BC Tubing KC XXX-P22 Tubing KC XXX-GG Tubing NP 105-1 Safety Strap KC 10 Tubing Separator KC XXX-5N Tubing BE 102 Tubing Clamp KC XXX-B Tubing KC XXX-N Tubing KC XXX Tubing KC XXX-6 Tubing KC XXX-P Tubing KC XXX-3 Tubing RB 001 BE 117 JEM 350 Endotracheal Tube Changer JEM 330 Endotracheal Tube Changer JEM 355 Endotracheal Tube Changer JEM 365 Endotracheal Tube Changer JEM 325 Endotracheal Tube Changer JEM 360 Endotracheal Tube Changer JEM 401 Set of 9 Endotracheal Tube Changers JEM 400 Endotracheal Tube Changer JEM 340 Endotracheal Tube Changer JEM 370 Endotracheal Tube Changer RTC 22-A RTC 23-A RTC 17-1 RTC 23-D RTC 22-D RTC 26-C BE 183-SU-12 BE 183-2 BE 183-SU BE 183-6 BE 183-SUR-12 BE 183-G BE 183-R BE 183-SUR BE 127 KC 212-D SG 102 KC 18901-L SG 101-D AM 100P BE 127-7.5 BE 195-1522A SG 101 PF 1510 BE 105-2X22 BE 193 PF 1515 BE 191 PF 001 BE 117-W BE 101-00-3443 BE 190 BE 125 KM 030 BE 101-00-1426 BE 127-7.5-40 BE 120-AKW BE 125-1TD KC 211-D BE 125-1T KC 18901-P KC 213-D NB 105-6 BE 192 KC 18901-K SG 1010 SG 218 BE 125-1 KC 18901-O BE 105-2X22D SG 193-M BE 105-2222 BE 127-40 PF 1010 SH 77-6 SH 77-3 SH 77-2 SH 77-1 SH 77-S (Set of 7 sizes) SH 77-5 SH 77-7 SH 77-4 NS 120P-TRS Pressure Gauge BE 122-30 Flexible Support Arm BE 122-2TB RB 002 BE 114-2 BE 114-1 BE 114-5 BE 114-5TB BE 122-24 Flexible Support Arm BE 122-2TSB BE 30-142 Magnetic PEEP valve BE 142 Magnetic PEEP valve SM-MH and SM-PH Laryngoscope Handles AM MAC Macintosh Laryngoscope Blades AM MIL Miller Laryngoscope Blades CI-55 Anesthesia Holster

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-04-12
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-26
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-11-26
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-11-26
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2014-11-14
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2018-04-25
BXR	Meter, Airway Pressure (Inspiratory Force)	Anesthesiology	Class 2	868.1780	2008-10-08
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2007-11-26
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2001-07-26
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2001-07-26
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2001-07-26
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-10-21
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-11-26
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2008-10-08
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	1977-12-30
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2009-03-27
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-11-26
LNZ	Changer, Tube, Endotracheal	Anesthesiology	Class 2	868.5730	2007-11-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-26
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2017-03-02
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-11-26
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	1977-12-30
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2001-07-26
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2019-05-21
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	1977-12-30
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2007-11-09
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2001-07-26

Official Correspondent

EDWARD HOREY, JR.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INSTRUMENTATION INDUSTRIES, INCORPORATED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518436. Last updated year: 2026. Please use registration number 2518436 when referencing this establishment in official correspondence.