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

CBQ — Predicate Candidate Screening

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

178 daysmedian FDA review time

374 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040917	PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B	Philips Medizin Systeme Boeblingen GmbH	2004-04-29	21	2
K994188	MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR,	Agilent Technologies, GmbH	2000-05-19	158	0
K962648	OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR	Ohmeda Medical	1997-01-17	193	0
K931439	OHMEDA MODEL 5330 ANESTHETIC MONITOR	Ohmeda Medical	1993-10-19	211	0
K926451	DATASCOPE MULTINEX II	Datascope Corp.	1993-08-25	244	0
K923433	AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE	Instrumentarium Corp.	1993-07-22	374	0
K923276	CAPNOMAC ULTIMA ANESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1993-07-21	380	0
K922876	AS/3 COP MODULE	Datex Division Instrumentarium Corp.	1993-07-21	401	0
K930303	DATASCOPE MULTINEX ID PLUS	Datascope Corp.	1993-06-16	146	0
K914295	ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED	Bruel & Kjaer	1992-04-10	214	0
K911644	NGM FRAME	Datex Division Instrumentarium Corp.	1992-03-04	324	0
K911647	NGM GAS MODULE	Datex Division Instrumentarium Corp.	1991-09-19	157	0
K903104	CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1991-01-23	194	0
K902021	RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR	Albion Instruments	1990-10-09	159	0
K892854	ANESTHETIC AGENT MONITOR	Criticare Systems, Inc.	1989-10-13	178	0
K892646	BIOCHEM 8100 ANESTHETIC AGENT MONITOR	Biochem International, Inc.	1989-08-31	141	0
K890606	OHMEDA 5330 AGENT MONITOR	Ohmeda Medical	1989-04-20	73	0
K883532	ICOR AGENT MONITOR	Icor AB	1988-11-04	78	0
K881264	PERMA PURE NAFION TUBE DRYER-MODEL ME	Perma Pure Products, Inc.	1988-10-25	215	0
K863248	PB GRAPHICS PRINTER AND PB VIDEO DISPLAY	Datex Division Instrumentarium Corp.	1986-09-03	12	0
K861397	OHMEDA 5300 ANESTHETIC AGENT MONITOR	Ohmeda Medical	1986-05-29	44	0
K861474	PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT	Datex Division Instrumentarium Corp.	1986-05-02	10	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