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

Datex Division Instrumentarium Corp. — Predicate Candidate Screening

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

100 daysmedian FDA review time

380 days90th percentile

55clearances measured

K-number	Device	Applicant	Decided	Review days
K953175	AS/3 ESTPR MODULE	Datex Division Instrumentarium Corp.	1997-02-06	580
K961247	AS/3 LIGHT MONITOR	Datex Division Instrumentarium Corp.	1996-10-23	205
K943458	AS/3 AIRWAY MODULE	Datex Division Instrumentarium Corp.	1995-02-14	211
K945234	AS/3 MEMORY MODULE, M0MEM	Datex Division Instrumentarium Corp.	1995-01-27	92
K933156	DATEX AS/3 PATIENT MONITOR	Datex Division Instrumentarium Corp.	1994-12-30	549
K933285	DATEX AS/3 TM ANAESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1994-11-14	496
K943456	AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT	Datex Division Instrumentarium Corp.	1994-10-17	91
K923172	ANAESTHESIA RECORD KEEPER	Datex Division Instrumentarium Corp.	1994-08-09	771
K935477	AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD	Datex Division Instrumentarium Corp.	1994-08-01	259
K943457	AS/3 PRESSURE TEMPERATURE MODULE, M-PT	Datex Division Instrumentarium Corp.	1994-07-27	9
K933284	AS/3 TM NETWORK	Datex Division Instrumentarium Corp.	1994-07-11	370
K932098	CAPNOMAC ULTIMA ANESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1993-11-29	210
K931422	DELTATRAC(TM) II METABOLIC MONITOR	Datex Division Instrumentarium Corp.	1993-11-24	247
K923276	CAPNOMAC ULTIMA ANESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1993-07-21	380
K922876	AS/3 COP MODULE	Datex Division Instrumentarium Corp.	1993-07-21	401
K911645	NGM NIBP MODULE	Datex Division Instrumentarium Corp.	1992-03-04	324
K911644	NGM FRAME	Datex Division Instrumentarium Corp.	1992-03-04	324
K911646	NGM ESTP MODULE	Datex Division Instrumentarium Corp.	1992-02-21	312
K911647	NGM GAS MODULE	Datex Division Instrumentarium Corp.	1991-09-19	157
K903237	CARDIOCAP CMX-104 MONITOR	Datex Division Instrumentarium Corp.	1991-07-17	359
K905754	CAPNOMAC ULTIMA ANESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1991-06-17	175
K905140	SATLITE PLUS PULSE OXIMETER	Datex Division Instrumentarium Corp.	1991-05-28	194
K910620	CARDIOCAP DR-124 RECORDER	Datex Division Instrumentarium Corp.	1991-05-07	84
K903104	CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1991-01-23	194
K896652	CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR	Datex Division Instrumentarium Corp.	1990-09-05	285
K902493	CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR	Datex Division Instrumentarium Corp.	1990-07-06	31
K902492	CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S	Datex Division Instrumentarium Corp.	1990-07-06	31
K896190	CARDIOCAP(TM) CMX-104 MONITOR	Datex Division Instrumentarium Corp.	1990-03-08	133
K897080	CARDIOCAP(TM) CT-104 MONITOR	Datex Division Instrumentarium Corp.	1990-03-06	75
K895780	OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER	Datex Division Instrumentarium Corp.	1989-11-29	63
K891076	CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR	Datex Division Instrumentarium Corp.	1989-08-02	155
K885058	CARDIOCAP(TM) DR-104 REPORTER	Datex Division Instrumentarium Corp.	1989-07-14	219
K884991	CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN	Datex Division Instrumentarium Corp.	1989-06-06	187
K890753	SATLITE TRANS PORTABLE PULSE OXIMETER	Datex Division Instrumentarium Corp.	1989-03-22	37
K884955	CARDIOCAP(TM) CM-104 MONITOR	Datex Division Instrumentarium Corp.	1988-12-28	29
K884956	CARDIOCAP(TM) CTO-104 MONITOR	Datex Division Instrumentarium Corp.	1988-12-27	28
K883877	BM-103 BATTERY MODULE	Datex Division Instrumentarium Corp.	1988-10-28	45
K882885	DATEX AIRWAY MONITOR	Datex Division Instrumentarium Corp.	1988-10-19	100
K882748	NORMOCAP 200 CAPNOMETER	Datex Division Instrumentarium Corp.	1988-10-19	106
K882093	CARDIOCAP(TM) CMO-104 MONITOR	Datex Division Instrumentarium Corp.	1988-07-28	70
K881883	SATLITE+/PB251+ PULSE OXIMETER	Datex Division Instrumentarium Corp.	1988-07-18	75
K873859	CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104	Datex Division Instrumentarium Corp.	1987-12-29	98
K872760	OSCAR(TM) PB255 OXIMETER CAPNOMETER	Datex Division Instrumentarium Corp.	1987-09-14	63
K871826	PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE	Datex Division Instrumentarium Corp.	1987-06-29	49
K870621	SATLITE/PB251 PULSE OXIMETER	Datex Division Instrumentarium Corp.	1987-03-20	36
K864603	DELTATRAC(TM) METABOLIC MONITOR	Datex Division Instrumentarium Corp.	1987-03-17	113
K862455	MODIFIED CARDIOCAP MONITOR	Datex Division Instrumentarium Corp.	1986-09-24	89
K863248	PB GRAPHICS PRINTER AND PB VIDEO DISPLAY	Datex Division Instrumentarium Corp.	1986-09-03	12
K861474	PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT	Datex Division Instrumentarium Corp.	1986-05-02	10
K861213	PB 254 IR - SPECTROMETER	Datex Division Instrumentarium Corp.	1986-04-04	4

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