Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2523148

FEI Number

2523148

Entity Name

PRECISION MEDICAL, INC.

City/State/Country

NORTHAMPTON, PA, US

Establishment Address

300 HELD DR., NORTHAMPTON, PA 18067, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Precision Medical, Inc (Owner Number: 2523148)

Owner / Operator Contact Address

300 HELD DR., --, Northampton, PA 18067, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PM500 Disposable Humidifier Vacuum Regulator Easy Go Vac PM15,COMPRESSOR,EASY AIR Endotracheal Tube Holder 1MFA, 3MFA, 4MFA, 5MFA, 6MFA, 8MFA Flowmeters HeliO2 Blender Easy Comp Compressor N2O Hoses AIR Hoses Neb Block Dial Flowmeter O2 Hoses Eliminator Flow Selector Vacuum Hoses Easy Pulse TOC Power Vac+ Aspirator Power Vac Aspirator Easy Vac Aspirator Precision Medical Blender Micromax Vacuum Regulator Easy Pulse 5+6 Oxygen Conserving Regulator Easy Pulse 5 Oxygen Conserving Regulator Easy Dial Reg Easy Gauge Reg

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2020-03-26
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2019-11-14
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2012-12-05
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2019-11-19
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	1992-07-30
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	1992-07-30
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2009-10-19
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2019-12-26
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	1992-07-30
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2009-06-17
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2019-11-14
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2006-02-14
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2006-06-26
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2005-11-21
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	1992-07-30

Official Correspondent

Lisa Whitman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Medical, Inc

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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26
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-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
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.

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3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2523148. Last updated year: 2026. Please use registration number 2523148 when referencing this establishment in official correspondence.