Laerdal Medical Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Laerdal Medical Corp.” (first 1982, latest 2000), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| BSR | Stylet, Tracheal Tube | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| CBP | Valve, Non-Rebreathing | 2 | 2 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 | 1 |
| KGB | Mask, Oxygen, Non-Rebreathing | 1 | 1 |
Review panels
Most recent Laerdal Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER | CBP | 2000-10-06 | 120 |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | BSR | 1996-09-05 | 78 |
| K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) | BSR | 1996-05-09 | 205 |
| K954609 | HEARTSTART 911 | MKJ | 1996-01-04 | 92 |
| K950698 | LSU 2000 PORTABLE SUCTION UNIT | JCX | 1995-05-09 | 88 |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | KGB | 1993-12-02 | 205 |
| K896919 | HEARTSTART 3000 | MKJ | 1990-05-03 | 142 |
| K880450 | RESUSCI PATIENT FACE SHIELD | BTM | 1988-03-04 | 31 |
| K861401 | LAERDAL POCKET MASK | CBP | 1986-05-21 | 36 |
| K840110 | LAERDAL SUCTION UNIT | BTA | 1984-03-12 | 62 |
1 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2026-01-13.
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 California, Inc. (5 510(k)s)
- Laerdal Medical AS (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 Corp.?
FDA lists 11 510(k) clearances under the applicant name “Laerdal Medical Corp.” (first 1982, latest 2000), across 7 product codes in 3 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 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laerdal Medical Corp. is 88 days.
Which FDA product codes appear under Laerdal Medical Corp.?
The most frequent FDA product codes under this applicant name are BSR (Stylet, Tracheal Tube, 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 2); CBP (Valve, Non-Rebreathing, 2).
Next steps
- See all 11 Laerdal Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code BSR, Laerdal Medical Corp.'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.