Data / Medical devices / United States / Precision Medical, Inc.

Precision Medical, Inc.: FDA-registered device maker in Northampton, PA, United States, 15 510(k) clearances

Name: Precision Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Precision Medical, Inc. is registered with the FDA (registration 2523148) in Northampton, PA, United States. It lists 13 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 2, 2018. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Precision Medical, Inc.

FDA registration number: 2523148
Address: 300 Held DR., Northampton, PA, United States, 18067
Owner or operator: Precision Medical, Inc (2523148)
Roles: Manufacturer
First device listed: July 30, 1992
Registered through: 2026
Brand names listed: 1MFA, 3MFA, 4MFA, 5MFA, 6MFA, 8MFA Flowmeters, AIR Hoses, Dial Flowmeter, Easy Comp Compressor, Easy Dial Reg, Easy Gauge Reg, Easy Go Vac, Easy Pulse 5 Oxygen Conserving Regulator and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Manufacturer	accessdata.fda.gov
Conserver, Oxygen	NFB	2	Manufacturer	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Manufacturer	accessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure Compensated	CAX	1	Manufacturer	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Manufacturer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Manufacturer	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Manufacturer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Manufacturer	accessdata.fda.gov
Regulator, Pressure, Gas Cylinder	CAN	1	Manufacturer	accessdata.fda.gov
Regulator, Vacuum	KDP	2	Manufacturer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 2, 2018	K173807	Accu O2 Oxygen Analyzer	CCL	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
July 1, 2011	K103563	PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150	CAW	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
August 13, 2009	K090781	HELIO2 BLENDER	BZR	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
October 27, 2008	K072348	PRECISION OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
February 27, 2007	K063096	PRECISION OXYGEN MONITOR	CCL	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
January 10, 2006	K053232	PRECISION BLENDER	BZR	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
August 25, 2003	K032018	EASY PULSE II OXYGEN CONSERVER	NFB	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
April 1, 1998	K971749	EASYGO ASPIRATOR	BTA	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
December 22, 1994	K944479	PM3300 INTERMITTENT VACUUM	KDP	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
December 12, 1994	K941818	PM9000 VAC TRAP	KDQ	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
October 28, 1994	K930509	PM PUMP COMPRESSOR	BTI	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
October 7, 1993	K932494	PM PUMP ASPIRATOR	BTA	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
March 4, 1993	K922817	PM3000 & PM3100 VACUUM REGULATOR	KDP	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
August 14, 1990	K902970	PRECISION MEDICAL DISPOSABLE HUMIDIFIER	BTT	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov
July 30, 1990	K902762	PM14 SOFT AIR COMPRESSOR	BTI	Substantially Equivalent	Precision Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 8, 2015	72449	Class II	Terminated	Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from.0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.	These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).	accessdata.fda.gov
March 5, 2010	55117	Not yet classified	Terminated	PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it	The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off"	accessdata.fda.gov
October 4, 2006	36547	Not yet classified	Terminated	Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067	Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.	accessdata.fda.gov
November 9, 2004	30500	Not yet classified	Terminated	Easy Go Vac Aspirator, Model PM65. Portable suction unit	Battery charger can be overcharged and overheat	accessdata.fda.gov

Compare with other makers

Updated May 2, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.