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

Ambu, Inc. — Predicate Candidate Screening

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

60 daysmedian FDA review time

225 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K051529	AMBU NEUROLINE GROUND	Ambu, Inc.	2005-08-04	56	0
K042682	AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR	Ambu, Inc.	2004-11-15	47	0
K042843	AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCI	Ambu, Inc.	2004-11-12	29	1
K041734	AMBU DISPOSABLE ECG ELECTRODE	Ambu, Inc.	2004-09-22	89	0
K040991	AMBU DISPOSABLE PRESSURE MANOMETER	Ambu, Inc.	2004-07-22	97	0
K041026	AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S	Ambu, Inc.	2004-06-28	68	0
K032278	AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE	Ambu, Inc.	2004-03-05	225	0
K032421	AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE	Ambu, Inc.	2004-02-27	206	0
K010583	AMBU GEL, HYDROGEL BURN DRESSING	Ambu, Inc.	2001-05-25	87	0
K993278	AMBU NEONATE SILICONE RESUSCITATOR	Ambu, Inc.	2000-05-17	230	0
K992902	AMBU HAND POWER SUCTION PUMP	Ambu, Inc.	1999-10-25	56	0
K982722	AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD	Ambu, Inc.	1999-04-12	250	0
K981891	AMBU TUBECHECK	Ambu, Inc.	1998-07-17	49	0
K964584	AMBU SPUR NEONATE	Ambu, Inc.	1997-05-15	181	0
K932031	AMBU PORTABLE SUCTION UNIT	Ambu, Inc.	1995-05-05	738	0
K932014	AMBU DISPOSABLE FACE MASK	Ambu, Inc.	1993-06-22	60	0
K923762	SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE	Ambu, Inc.	1993-02-05	192	0
K923976	AMBU SINGLE PATIENT USE PEEP VALVE	Ambu, Inc.	1993-01-05	151	0
K924215	AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR	Ambu, Inc.	1992-09-16	43	0
K924216	AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO	Ambu, Inc.	1992-09-16	43	0
K922712	SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM	Ambu, Inc.	1992-06-19	14	0
K922707	SPUR ADULT WITH OPEN RESERVOIR SYSTEM	Ambu, Inc.	1992-06-19	14	0
K914187	AMBU SILICONE RESUSCITATOR INFANT/CHILD	Ambu, Inc.	1991-10-07	19	0
K904920	AMBU MATIC AUTOMATIC RESUSCITATOR	Ambu, Inc.	1991-05-28	209	0
K910040	AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT	Ambu, Inc.	1991-05-28	144	0
K902261	AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT	Ambu, Inc.	1990-07-16	56	0
K900260	AMBU LIFE KEY AND AMBU RES-CUE KEY	Ambu, Inc.	1990-06-08	142	0
K883434	AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)	Ambu, Inc.	1988-09-14	30	0
K883433	AMBU TWIN PUMP - (MANUAL SUCTION PUMP)	Ambu, Inc.	1988-09-02	18	0
K873579	AMBU RMT VALVE	Ambu, Inc.	1987-12-30	118	0
K851194	AMBU CPAP SYSTEM	Ambu, Inc.	1985-04-15	20	0
K844149	AMBU RUBEN CIRCLE ANESTHESIA SYSTEM	Ambu, Inc.	1984-11-15	22	0
K840349	MARK III RESUSCITATOR	Ambu, Inc.	1984-02-10	15	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