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

Datex Ohmeda — Predicate Candidate Screening

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

66 daysmedian FDA review time

141 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231964	Novii+ Wireless Patch System	Datex Ohmeda	2023-12-08	158	0
K131945	GE DATEX-OHMEDA AVANCE CS2	Datex-Ohmeda	2013-08-08	42	1
K122445	AESPIRE 7900, AESPIRE VIEW	Datex-Ohmeda	2012-10-12	63	4
K111116	ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 15	Datex-Ohmeda	2011-09-09	141	4
K071142	GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM	Datex-Ohmeda	2007-06-06	43	0
K042891	DATEX-OHMEDA OXY-AFR SENSOR	Datex-Ohmeda	2005-06-29	253	0
K043572	COMPATIBILITY ECG TRUNK CABLES	Datex-Ohmeda	2005-02-22	57	0
K043551	DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP	Datex-Ohmeda	2005-02-18	57	0
K043276	DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE A	Datex-Ohmeda	2004-12-23	27	1
K042771	GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION	Datex-Ohmeda	2004-10-15	10	0
K041772	DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND	Datex-Ohmeda	2004-07-28	27	0
K041790	DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AN	Datex-Ohmeda	2004-07-23	21	0
K032803	DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM	Datex-Ohmeda	2004-03-10	183	0
K033281	DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-N	Datex-Ohmeda	2003-11-26	43	0
K033078	DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB	Datex-Ohmeda	2003-10-29	30	0
K030990	DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR	Datex-Ohmeda	2003-06-25	89	0
K031781	DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCE	Datex-Ohmeda	2003-06-25	15	0
K031653	DATEX-OHMEDA HMEF 750	Datex-Ohmeda	2003-06-20	23	0
K030812	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A	Datex-Ohmeda	2003-05-21	68	0
K023454	DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCE	Datex-Ohmeda	2003-04-23	190	0
K023459	DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES	Datex-Ohmeda	2003-01-13	90	0
K023641	DATEX-OHMEDA HMEF MINI	Datex-Ohmeda	2002-11-27	28	0
K022740	DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02	Datex-Ohmeda	2002-11-14	87	2
K023497	DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE	Datex-Ohmeda	2002-11-04	17	0
K022485	DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AN	Datex-Ohmeda	2002-10-03	66	0
K021265	DATEX-OHMEDA HMEF 500	Datex-Ohmeda	2002-08-30	130	0
K022507	DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02	Datex-Ohmeda	2002-08-23	24	0
K021376	DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-IC	Datex-Ohmeda	2002-07-24	84	0
K021279	DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02	Datex-Ohmeda	2002-07-19	88	0
K020479	DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSA	Datex-Ohmeda	2002-03-26	41	0
K013389	DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES	Datex-Ohmeda	2002-01-10	90	0
K013387	DATEX-OHMEDA S/5 WEB VIEWER	Datex-Ohmeda	2002-01-08	88	0
K013246	DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01	Datex-Ohmeda	2001-12-11	74	0
K012531	DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX	Datex-Ohmeda	2001-11-02	88	0
K012837	MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESS	Datex-Ohmeda	2001-09-14	22	2
K011670	DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIE	Datex-Ohmeda	2001-06-26	27	1
K001814	DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERS	Datex-Ohmeda	2000-08-23	69	0
K000815	AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)	Datex-Ohmeda	2000-06-08	87	0
K000882	DATEX-OHMEDA CS/3 TELEMETRY SYSTEM	Datex-Ohmeda	2000-06-05	77	0
K000168	CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)	Datex-Ohmeda	2000-04-13	84	0
K000186	DATEX-OHMEDA INOVENT DELIVERY SYSTEM	Datex-Ohmeda	2000-02-10	27	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