Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

CAX — Predicate Candidate Screening

24 FDA 510(k) clearances under this product code; the 50 most recent screened below.

28 daysmedian FDA review time

78 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K923781	MXR-2000 FLOWMETER	Porter Instrument Co., Inc.	1993-06-10	317	1
K910316	OHMEDA - LOW FLOW FLOWMETER	Ohmeda Medical	1991-04-12	78	0
K884973	FR6000 FLOWMETER	Key Instruments	1989-01-17	48	0
K872718	SERIES D FLOWMETER	Puritan Bennett Corp.	1987-08-05	26	0
K871452	CLASSIC (TM) 200 OXYGEN FLOWMETER	The Timeter Group	1987-06-22	70	0
K862797	AIRCO 2000 SERIES FLOWMETERS	Airco, Inc.	1986-08-08	17	0
K854067	SELECT FLOWMETER	Precision Medical, Inc.	1985-10-29	25	0
K851288	OXYGEN DELIVERY MEASURING DEVICE	Bar-Dix, Inc.	1985-09-03	155	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
K834260	RECON-2 FLOW CONTROLLER	Precision Metering, Inc.	1984-01-10	34	0
K812419	PRESET FLOWMETER	Timeter Instrument Corp.	1981-09-21	28	0
K812183	TIMETER-PRODUCED PURITAN BENNETT AIR ADP	Timeter Instrument Corp.	1981-08-18	15	0
K812128	RECON 1	Precision Metering, Inc.	1981-08-18	22	0
K802659	RESPIRATORY THERAPY FLOWMETER	Design & Manufacturing Consultants	1980-11-12	19	0
K802311	MO8 OXYGEN FLOWMETER	Timeter Instrument Corp.	1980-10-23	30	0
K791900	M015 OXYGEN & MA15 AIR	Timeter Instrument Corp.	1979-10-11	16	0
K791648	MODEL 54 FLOWMETER BACK-PRESSURE TUBE	Harris Calorific	1979-09-17	24	0
K791220	FLOWMETER, BACK PRESSURE COMPENSATED,	Timeter Instrument Corp.	1979-08-03	31	0
K791017	FLOW LIMITER	Timeter Instrument Corp.	1979-07-03	32	0
K791069	LINDE OXYGEN THERAPY FLOWMETERS, L33-L34	Union Carbide Corp.	1979-06-27	15	0
K781541	FLOMETER	Chemetron Medical Products, Inc.	1978-09-26	18	0
K760314	FLOWMETER, OXYGEN	Harris-Lake, Inc.	1976-08-04	9	0
K760102	FLOWMETER, P.C., REDESIGNED VERSION	Ohio Medical Products	1976-07-16	23	0

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