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

Ambu A/S — Predicate Candidate Screening

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

144 daysmedian FDA review time

309 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260578	Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US,	Ambu A/S	2026-07-14	144	0
K251583	Ambu® Virobac II® Exhalation Filter	Ambu A/S	2026-04-30	342	0
K250269	Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope	Ambu A/S	2025-06-11	132	0
K240849	Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope	Ambu A/S	2024-10-16	203	0
K240848	Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope	Ambu A/S	2024-10-10	197	0
K242108	Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™	Ambu A/S	2024-08-16	29	0
K233630	Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™	Ambu A/S	2024-06-24	224	0
K233886	Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2	Ambu A/S	2024-04-16	130	0
K232919	Ambu® aScope™ Gastro Large; Ambu® aBox™ 2	Ambu A/S	2024-04-05	199	0
K233671	Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7	Ambu A/S	2024-01-04	50	0
K232582	Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set	Ambu A/S	2023-09-20	26	1
K230332	Ambu® aScope™ Colon; Ambu® aBox™ 2	Ambu A/S	2023-09-15	220	0
K230428	Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2	Ambu A/S	2023-08-10	174	0
K223299	Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho	Ambu A/S	2023-06-01	217	1
K223782	Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5	Ambu A/S	2023-01-12	27	0
K220606	Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5	Ambu A/S	2022-07-25	145	0
K212382	Ambu® aScope™ Gastro, Ambu® aBox™2	Ambu A/S	2022-02-03	185	0
K210883	aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Bronc	Ambu A/S	2021-06-17	84	0
K203749	Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable	Ambu A/S	2021-05-03	131	1
K193095	Ambu aScope 4 Cysto	Ambu A/S	2020-04-02	147	0
K190972	Ambu aScope 4 RhinoLaryngo Intervention	Ambu A/S	2019-07-12	88	0
K191080	Ambu aScope 4 RhinoLaryngo Slim	Ambu A/S	2019-05-22	28	0
K181286	Ambu aScope RLS Slim	Ambu A/S	2018-11-30	198	0
K173727	Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.	Ambu A/S	2018-03-28	113	0
K161656	Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, A	Ambu A/S	2016-09-01	77	0
K152931	Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resu	Ambu A/S	2016-08-29	329	1
K160766	Ambu USR, Ambu M	Ambu A/S	2016-08-17	149	0
K130845	AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIE	Ambu A/S	2013-11-01	220	0
K110962	AMBU ASCOPE 2	Ambu A/S	2011-11-18	226	0
K102824	AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC	Ambu A/S	2011-01-28	121	0
K100129	AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X	Ambu A/S	2010-06-11	143	0
K093186	AMBU ASCOPE AND MONITOR	Ambu A/S	2010-04-16	189	0
K093825	AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE	Ambu A/S	2010-01-13	30	0
K071186	MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE	Ambu A/S	2007-07-30	91	0
K071185	MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE	Ambu A/S	2007-05-30	30	0
K052944	AMBU WHITE SENSOR CFM, CFL	Ambu A/S	2006-10-25	370	0
K053550	AMBU BLUE SENSOR NEO AND NEO X	Ambu A/S	2006-10-25	309	0
K053140	AMBU MARK IV RESUSCITATOR	Ambu A/S	2005-12-23	44	0
K053142	AMBU MARK IV BABY RESUSCITATOR	Ambu A/S	2005-12-20	41	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