Ambu A/S: FDA filings under this applicant name

FDA lists 41 510(k) clearances under the applicant name “Ambu A/S” (first 2005, latest 2026), across 15 product codes in 6 review panels. Median 510(k) review time under this name: 144 days. Since 2017 the median was 144 days, against 164 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Ambu A/S took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.

Top product codes

Plus 5 more product codes.

Review panels

• Ear, Nose and Throat (14)
• Gastroenterology and Urology (12)
• Anesthesiology (7)
• Neurology (4)
• Cardiovascular (3)
• General Hospital (1)

Most recent Ambu A/S 510(k) clearances

31 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Ambu A/S.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Ambu A/S is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT04628949: A Single-Use Duodenoscope in a Real-World Setting (Completed, started 2021-01-25)
• NCT04190641: Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder (Completed, started 2020-10-08)
• NCT04192474: Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy (Completed, started 2020-07-21)
• NCT04128527: AuraOnce Performance Observation (Completed, started 2019-10-09)
• NCT03294213: Prospective Non-interventional Evaluation of Intubation and Intensive Care Use of the New aScope™ 4 Broncho and aView (Completed, started 2017-09-25)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Ambu, Inc. (33 510(k)s)
• Ambu Innovation GmbH (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Ambu A/S?

FDA lists 41 510(k) clearances under the applicant name “Ambu A/S” (first 2005, latest 2026), across 15 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Ambu A/S?

The median time from FDA receipt to decision across 510(k)s cleared under the name Ambu A/S is 144 days. Since 2017: 144 days, versus 164 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Ambu A/S?

The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 11); FAJ (Cystoscope And Accessories, Flexible/Rigid, 5); BTM (Ventilator, Emergency, Manual (Resuscitator), 4).

Next steps

• See all 41 Ambu A/S clearances with predicates and recalls
• Run predicate analysis for product code EOQ, Ambu A/S's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

All FDA device companies · FDA product code lookup