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

Draeger Medical, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time

191 days90th percentile

78clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K042607	PRIMUS US	Draeger Medical, Inc.	2004-11-26	63	2
K042419	FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM	Draeger Medical, Inc.	2004-10-08	31	9
K042276	D-VAPOR	Draeger Medical, Inc.	2004-09-23	31	0
K042086	FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM	Draeger Medical, Inc.	2004-08-31	28	0
K041622	MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANE	Draeger Medical, Inc.	2004-07-08	22	0
K040847	MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR	Draeger Medical, Inc.	2004-06-17	77	0
K033498	NARKOMED 6400, MODEL NM6400	Draeger Medical, Inc.	2004-04-26	173	1
K030624	MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM	Draeger Medical, Inc.	2004-03-17	384	0
K031400	FABIUS TIRO ANESTHESIA SYSTEM	Draeger Medical, Inc.	2003-07-15	71	0
K022031	NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2	Draeger Medical, Inc.	2002-08-29	69	0
K011404	FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS	Draeger Medical, Inc.	2002-02-22	290	0
K012139	VAMOS ANESTHETIC GAS MONITOR	Draeger Medical, Inc.	2002-01-17	191	0
K003579	NARKOMED MRI-2, MODEL NM-MRI-2	Draeger Medical, Inc.	2001-01-22	63	0
K001488	NARKOMED MRI , NM-MRI	Draeger Medical, Inc.	2000-06-09	28	0
K993826	NARKOMED 6000	Draeger Medical, Inc.	2000-03-23	132	0
K983635	JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN	Draeger Medical, Inc.	1999-01-11	88	0
K980553	NARKOMED 6000 MODEL NUMBER NM6000	Draeger Medical, Inc.	1998-08-04	173	0
K980208	DIVAN ANESTHESIA VENTILATOR	Draeger Medical, Inc.	1998-08-04	196	0
K981773	DRAGER-VAPOR 19.3	Draeger Medical, Inc.	1998-07-06	47	0
K980886	BABYTHERM 8000 LDR	Draeger Medical, Inc.	1998-05-29	81	0
K981472	DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS	Draeger Medical, Inc.	1998-05-07	13	0
K973949	PERIOPERATIVE DATA MANAGEMENT SYSTEM	Draeger Medical, Inc.	1998-02-06	113	0
K974193	NARKOMED ULTRASONIC FLOW SENSOR	Draeger Medical, Inc.	1998-01-28	82	0
K973051	DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS	Draeger Medical, Inc.	1997-10-30	76	0
K972848	NARKOMED MRI ANESTHESIA SYSTEM	Draeger Medical, Inc.	1997-10-30	90	0
K971923	DRAGER-VAPOR 2000	Draeger Medical, Inc.	1997-09-16	116	2
K971425	NARKOMED M ANESTHESIA SYSTEM (M)	Draeger Medical, Inc.	1997-09-10	146	0
K963994	NARKOMED GS ANESTHESIA SYSTEM	Draeger Medical, Inc.	1997-03-19	166	0
K953228	NARKOMED AV2+ ANESTHESIA VENTILATOR	Draeger Medical, Inc.	1996-03-01	235	0
K945463	PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM	Draeger Medical, Inc.	1995-02-03	88	0
K930351	NARKOMED 2C ANESTHESIA SYSTEM	Draeger Medical, Inc.	1993-06-22	148	0
K913995	VITALERT 3000 MONITORING SYSTEM	Draeger Medical, Inc.	1992-11-03	424	0
K912533	NARKOMED AV-E VENTILATOR	Draeger Medical, Inc.	1991-07-25	48	0
K901713	NARKOMED 4 ANESTHESIA SYSTEM	Draeger Medical, Inc.	1990-07-09	87	0
K900937	O.R. DATA MANAGER	Draeger Medical, Inc.	1990-04-05	36	0
K900328	NARKOMED 2B ANESTHESIA SYSTEM	Draeger Medical, Inc.	1990-02-01	9	0
K900329	NARKOMED 3 ANESTHESIA SYSTEM	Draeger Medical, Inc.	1990-02-01	9	0
K882031	VITALERT 2000 VITAL SIGNS MONITOR	Draeger Medical, Inc.	1988-07-28	73	0
K873380	VITALERT 1000 MONITORING SYSTEM	Draeger Medical, Inc.	1988-04-14	234	0
K874415	PRESSURE LIMIT CONTROL	Draeger Medical, Inc.	1988-01-11	75	0
K874371	ASCENDING VENTILATOR BELLOWS	Draeger Medical, Inc.	1987-12-11	46	0
K873194	SPECTRAMED RESPIRATORY GAS ANALYZER	Draeger Medical, Inc.	1987-10-30	78	0
K873549	PEDIATRIC BELLOWS	Draeger Medical, Inc.	1987-10-08	38	0
K871886	MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT	Draeger Medical, Inc.	1987-07-29	76	0
K862427	MODIFIED DRAGER SPHYGMOMED	Draeger Medical, Inc.	1987-03-23	270	0
K864447	NARKOMED 2B ANESTHESIA SYSTEM	Draeger Medical, Inc.	1987-01-27	76	0
K864806	ANESTHESIA RECORDER	Draeger Medical, Inc.	1987-01-15	37	0
K864431	PEDIATRIC BELLOWS	Draeger Medical, Inc.	1987-01-12	61	0
K864034	OPEN RESERVOIR SCAVENGER	Draeger Medical, Inc.	1986-12-15	61	0
K862426	PULSE OXIMETER	Draeger Medical, Inc.	1986-09-11	77	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