Ambu, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Ambu, Inc.” (first 1984, latest 2005), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 60 days. 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 15 | 15 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
Plus 6 more product codes.
Review panels
- Anesthesiology (25)
- Cardiovascular (3)
- General and Plastic Surgery (3)
- Neurology (2)
Most recent Ambu, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051529 | AMBU NEUROLINE GROUND | GXY | 2005-08-04 | 56 |
| K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR | BTM | 2004-11-15 | 47 |
| K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS | BTM | 2004-11-12 | 29 |
| K041734 | AMBU DISPOSABLE ECG ELECTRODE | DRX | 2004-09-22 | 89 |
| K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | CAP | 2004-07-22 | 97 |
| K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S | DRX | 2004-06-28 | 68 |
| K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE | GXY | 2004-03-05 | 225 |
| K032421 | AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE | MKJ | 2004-02-27 | 206 |
| K010583 | AMBU GEL, HYDROGEL BURN DRESSING | MGQ | 2001-05-25 | 87 |
| K993278 | AMBU NEONATE SILICONE RESUSCITATOR | BTM | 2000-05-17 | 230 |
23 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 6 initiated in the last five years. Most recent: 2025-07-09.
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, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04829461: Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy (Completed, started 2021-04-27)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ambu, Inc. (a text match, not an official crosswalk):
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 A/S (41 510(k)s)
- Ambu Innovation GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ambu, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Ambu, Inc.” (first 1984, latest 2005), across 16 product codes in 4 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ambu, Inc. is 60 days.
Which FDA product codes appear under Ambu, Inc.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 15); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 2); DRX (Electrode, Electrocardiograph, 2).
Next steps
- See all 33 Ambu, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Ambu, Inc.'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.