Laerdal Medical AS: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Laerdal Medical AS” (first 2015, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 92 days. Since 2017 the median was 136 days, against 214 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
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 50 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 53 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 347 |
| 2025 | 1 | 180 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Laerdal Medical AS took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIX | Aid, Cardiopulmonary Resuscitation | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
- Cardiovascular (4)
- Anesthesiology (1)
Most recent Laerdal Medical AS 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessories | BTM | 2025-11-24 | 180 |
| K232111 | NeoBeat, NeoBeat Mini | MWI | 2024-06-25 | 347 |
| K183348 | Reusable Silicone Cover CPRmeter 2 | LIX | 2018-12-17 | 14 |
| K173886 | CPRmeter 2 CPR Feedback Device | LIX | 2018-03-23 | 92 |
| K151702 | Reusable Full Silicone Cover | LIX | 2015-08-13 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Laerdal Medical AS.
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.
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.
- Laerdal Medical Corp. (11 510(k)s)
- Laerdal California, Inc. (5 510(k)s)
- Laerdal Mfg. Corp. (5 510(k)s)
- Laerdal Medical A/S (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Laerdal Medical AS?
FDA lists 5 510(k) clearances under the applicant name “Laerdal Medical AS” (first 2015, latest 2025), across 3 product codes in 2 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 Laerdal Medical AS?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laerdal Medical AS is 92 days. Since 2017: 136 days, versus 214 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Laerdal Medical AS?
The most frequent FDA product codes under this applicant name are LIX (Aid, Cardiopulmonary Resuscitation, 3); BTM (Ventilator, Emergency, Manual (Resuscitator), 1); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 1).
Next steps
- See all 5 Laerdal Medical AS clearances with predicates and recalls
- Run predicate analysis for product code LIX, Laerdal Medical AS'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.