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

FMZ — Predicate Candidate Screening

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

91 daysmedian FDA review time

282 days90th percentile

86clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260326	Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Care	Datex-Ohmeda, Inc.	2026-07-28	179	0
K251619	Babyleo TN500	Drägerwerk AG & Co. KGaA	2026-02-13	262	0
K251663	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Caresta	Datex-Ohmeda, Inc.	2025-10-22	145	0
K243437	mOm Essential Incubator (ME1)	Mom Incubators Limited	2025-08-14	282	0
K213553	Giraffe Incubator Carestation CS1	Datex Ohmeda, Inc.	2022-03-02	114	1
K190494	Infant Incubator	Ningbo David Medical Device Co., Ltd.	2019-11-25	270	0
K182859	Babyleo TN500	Dragerwerk AG & CO Kgaa	2019-02-22	134	0
K182977	Isolette 8000 Plus	Draeger Medical Systems, Inc.	2018-11-21	26	0
K172154	Isolette 8000 plus	Draeger Medical Sytems, Inc.	2018-04-19	276	0
K162821	Babyleo TN500	Draegerwerk AG & CO Kgaa	2017-06-23	259	0
K152814	Giraffe OmniBed Carestation CS1	Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company	2016-03-17	171	6
K152809	Giraffe Incubator Carestation CS1	Ohmeda Medical, A Division of Datex-Ohmeda, Inc.	2015-12-31	94	2
K132543	INFANT INCUBATOR	Bistos Co., Ltd.	2014-07-03	324	0
K102226	DUAL INCU I	Atom Medical Corporation	2011-01-04	148	5
K102279	INCU I	Atom Medical Corporation	2010-12-29	140	0
K102710	NEO-SERVO I	Atom Medical Corporation	2010-12-22	93	0
K101778	GIRAFFE INCUBATOR	Ohmeda Medical	2010-07-21	26	1
K101788	GIRAFFE OMNIBED	Ohmeda Medical	2010-07-21	26	7
K071977	TARRY MEDICAL TEMPERATURE PROBES	Tarry Medical Products, Inc.	2008-05-23	311	0
K072512	MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE A	Datex-Ohmeda, Inc.	2007-10-03	27	0
K070291	MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE	Medix I.C.S.A.	2007-09-21	234	2
K071175	OHMEDA MEDICAL GIRAFFE OMNIBED	GE Healthcare	2007-07-17	81	0
K061856	V-2200 INFANT INCUBATOR	Atom Medical, Inc.	2006-09-28	90	0
K053399	VERSALET 7700 CARE CENTER	Draeger Medical Infant Care, Inc.	2006-08-04	241	0
K061280	V-2200 INFANT INCUBATOR	Neoforce Group, Inc.	2006-06-27	50	0
K040910	INFANT INCUBATOR, MODEL CHS-I1000	Choong Wae Medical Corp.	2004-04-21	13	0
K040068	BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM	Ohmeda Medical	2004-04-16	93	0
K031387	ISOLETTE INFANT INCUBATOR, MODEL C2000E	Hill-Rom Manufacturing, Inc.	2003-08-01	91	0
K021809	V-2100G ADVANCED INFANT INCUBATOR	Atom Medical Corp	2002-07-18	45	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
K010222	OHMEDA MEDICAL GIRAFFE INCUBATOR	Ohmeda Medical	2001-03-21	56	1
K003067	CALEO	Drager Medizintechnik GmbH	2000-12-13	72	0
K001242	ISOLETTE INFANT INCUBATOR, MODEL C2HS	Hill-Rom Air-Shields	2000-07-13	86	0
K993051	VERSALET 7700 CARE CENTER, MODEL # 7700	Hill-Rom Air-Shields	2000-02-03	143	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
K980886	BABYTHERM 8000 LDR	Draeger Medical, Inc.	1998-05-29	81	0
K974349	OHMEDA-OHIO CARE PLUS INCUBATOR	Ohmeda Medical	1998-02-12	85	1
K954204	DRAGER INCUBATOR 8000 IC	Drager, Inc.	1997-04-25	597	0
K962806	OHMEDA-OHIO CAE PLUS INCUBATOR	Ohmeda Medical	1996-09-20	64	1
K960980	ISOLETTE INFANT INCUBATOR	Air-Shields, Inc.	1996-07-30	141	0
K943360	OHIO CARE PLUS INCUBATOR	Ohmeda Medical	1994-09-29	79	1
K940975	C450/C400 INFANT INCUBATORS	Air-Shields, Inc.	1994-06-23	112	0
K924324	K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE	K-1 Medical Products, Inc.	1993-11-12	442	0
K922618	BOWRON	G.L. Bowron & Co. , Ltd.	1993-08-19	443	0
K920049	MEDIX PC-305 NEONATAL INCUBATOR	Medix I.C.S.A.	1993-05-21	501	0
K924297	DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER	Air-Shields Vickers, Inc.	1993-03-18	204	0
K924170	ISOLETTE INCUBATOR HUMIDITY METER	Air-Shields, Inc.	1993-02-05	170	0
K912000	TYPE INTERFACE 9271/1 INCUBATOR/WARMER	S & W Medico Teknik	1992-09-21	516	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