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

Ohmeda Medical · Predicate Candidate Screening

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

79 daysmedian FDA review time

316 days90th percentile

120clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K123309	GIRAFFE AND PANDA WARMERS	Ohmeda Medical	2013-02-05	104	9
K101778	GIRAFFE INCUBATOR	Ohmeda Medical	2010-07-21	26	1
K101788	GIRAFFE OMNIBED	Ohmeda Medical	2010-07-21	26	7
K090697	MODIFICATION TO: GIRAFFE AND PANDA WARMER	Ohmeda Medical	2009-04-16	30	1
K072157	MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA	Ohmeda Medical	2007-08-27	24	0
K070377	GIRAFFE AND PANDA WARMER	Ohmeda Medical	2007-07-11	153	2
K070210	GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM	Ohmeda Medical	2007-04-20	88	5
K070247	GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM	Ohmeda Medical	2007-04-20	85	5
K040068	BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM	Ohmeda Medical	2004-04-16	93	0
K020547	OHMEDA MEDICAL GIRAFFE INCUBATOR	Ohmeda Medical	2002-05-09	79	2
K020543	OHMEDA MEDICAL GIRAFFE OMNIBED	Ohmeda Medical	2002-05-09	79	8
K010388	SONDREX P.A.L. SYSTEM	Ohmeda Medical	2001-12-11	306	0
K011549	OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM	Ohmeda Medical	2001-07-19	62	0
K010222	OHMEDA MEDICAL GIRAFFE INCUBATOR	Ohmeda Medical	2001-03-21	56	1
DEN000001	OHMEDA INOVENT DELIVERY SYSTEM	Ohmeda Medical	2000-01-11	4	0
K993407	OHMEDA MEDICAL OMNIBED	Ohmeda Medical	2000-01-05	89	1
K993712	BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM	Ohmeda Medical	1999-11-09	6	0
K973896	OHMEDA EXCEL 3000 ANESTHESIA SYSTEM	Ohmeda Medical	1998-04-21	189	1
K974349	OHMEDA-OHIO CARE PLUS INCUBATOR	Ohmeda Medical	1998-02-12	85	1
K974083	CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCK	Ohmeda Medical	1998-01-13	76	2
K974374	SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV	Ohmeda Medical	1998-01-02	43	0
K971243	OHMEDA INFANT RESUSCITATION SYSTEM	Ohmeda Medical	1997-12-02	243	0
K965041	OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM	Ohmeda Medical	1997-06-17	182	0
K962648	OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR	Ohmeda Medical	1997-01-17	193	0
K962127	OHMEDA 3800 PULSE OXIMETER	Ohmeda Medical	1996-10-10	129	0
K946127	OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM	Ohmeda Medical	1996-10-08	663	0
K963058	INFANT WARMER SYSTEM	Ohmeda Medical	1996-10-01	56	1
K960964	OHMEDA 7900 ANESTHESIA VENTILATOR	Ohmeda Medical	1996-09-27	200	0
K962806	OHMEDA-OHIO CAE PLUS INCUBATOR	Ohmeda Medical	1996-09-20	64	1
K944052	RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR	Ohmeda Medical	1995-07-07	322	0
K942091	OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE	Ohmeda Medical	1995-03-30	332	0
K935090	CUFF-CATH	Ohmeda Medical	1994-10-14	357	0
K931304	OHMEDA HAND HELD OXIMETER	Ohmeda Medical	1994-09-29	563	0
K943360	OHIO CARE PLUS INCUBATOR	Ohmeda Medical	1994-09-29	79	1
K935782	DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSO	Ohmeda Medical	1994-08-01	238	9
K941428	EXACTA PERCUTANEOUS INTRODUCER SHEATH	Ohmeda Medical	1994-07-06	104	2
K936182	CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT	Ohmeda Medical	1994-03-25	88	0
K935274	DIPRIVAN LUER CONNECTOR	Ohmeda Medical	1994-03-15	132	0
K931439	OHMEDA MODEL 5330 ANESTHETIC MONITOR	Ohmeda Medical	1993-10-19	211	0
K921742	OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY	Ohmeda Medical	1993-05-26	408	0
K930866	RASCAL II	Ohmeda Medical	1993-05-13	83	0
K921766	OHIO INFANT WARMER SYSTEM	Ohmeda Medical	1993-04-23	374	1
K920622	RASCAL II	Ohmeda Medical	1992-10-13	245	0
K913593	OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER	Ohmeda Medical	1992-10-06	420	0
K920590	OHMEDA MODEL 5250 RGM MONITOR	Ohmeda Medical	1992-08-31	203	0
K910571	BILIBLANKET LIGHT METER	Ohmeda Medical	1992-07-28	533	0
K910929	OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.	Ohmeda Medical	1992-03-19	380	0
K914487	OHIO CARE PLUS INCUBATOR	Ohmeda Medical	1991-12-18	71	1
K913154	OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION	Ohmeda Medical	1991-09-13	63	0
K911193	OHMEDA MODEL 4700 OXICAP	Ohmeda Medical	1991-08-02	137	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