Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Precision Medical, Inc. — Predicate Candidate Screening

30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

140 daysmedian FDA review time

324 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K173807	Accu O2 Oxygen Analyzer	Precision Medical, Inc.	2018-05-02	138	0
K140179	EASY GO VAC	Precision Medical, Inc.	2014-04-25	91	0
K103563	PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150	Precision Medical, Inc.	2011-07-01	207	0
K103324	PRECISION LIQUID OXYGEN SYSTEM	Precision Medical, Inc.	2011-04-21	160	0
K090781	HELIO2 BLENDER	Precision Medical, Inc.	2009-08-13	143	0
K072348	PRECISION OXYGEN CONCENTRATOR	Precision Medical, Inc.	2008-10-27	433	0
K063096	PRECISION OXYGEN MONITOR	Precision Medical, Inc.	2007-02-27	140	0
K053232	PRECISION BLENDER	Precision Medical, Inc.	2006-01-10	53	0
K051691	MINIMATE COMPRESSOR	Precision Medical, Inc.	2005-12-09	169	0
K041122	PRECISION LIQUID OXYGEN SYSTEM	Precision Medical, Inc.	2004-10-04	158	1
K032018	EASY PULSE II OXYGEN CONSERVER	Precision Medical, Inc.	2003-08-25	56	0
K001412	PM 1800 CONSERVING DEVICE	Precision Medical, Inc.	2001-03-20	320	0
K971749	EASYGO ASPIRATOR	Precision Medical, Inc.	1998-04-01	324	2
K944479	PM3300 INTERMITTENT VACUUM	Precision Medical, Inc.	1994-12-22	100	0
K941818	PM9000 VAC TRAP	Precision Medical, Inc.	1994-12-12	243	0
K942350	CAREPAK	Precision Medical, Inc.	1994-12-06	203	0
K930509	PM PUMP COMPRESSOR	Precision Medical, Inc.	1994-10-28	634	0
K932006	1500 SERIES REGULATOR	Precision Medical, Inc.	1993-10-25	187	0
K932494	PM PUMP ASPIRATOR	Precision Medical, Inc.	1993-10-07	136	0
K922817	PM3000 & PM3100 VACUUM REGULATOR	Precision Medical, Inc.	1993-03-04	266	0
K923324	PRECISION MIST COMPRESSOR	Precision Medical, Inc.	1993-01-14	191	0
K901831	PRECISION MEDICAL OXYGEN REGULATOR	Precision Medical, Inc.	1990-08-14	112	1
K902970	PRECISION MEDICAL DISPOSABLE HUMIDIFIER	Precision Medical, Inc.	1990-08-14	39	0
K902762	PM14 SOFT AIR COMPRESSOR	Precision Medical, Inc.	1990-07-30	35	0
K902916	PRECISION MEDICAL NEB BLOCK	Precision Medical, Inc.	1990-07-23	20	0
K902917	PRECISION MEDICAL ELIMINATOR	Precision Medical, Inc.	1990-07-23	20	0
K854067	SELECT FLOWMETER	Precision Medical, Inc.	1985-10-29	25	0
K850559	PRESSURE RELIEF ADAPTOR	Precision Medical, Inc.	1985-04-25	72	0
K850560	FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE	Precision Medical, Inc.	1985-04-17	64	0
K843223	FLOW CONTROLLER	Precision Medical, Inc.	1984-09-27	42	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda