Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laerdal Medical AS · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
347 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessories | Laerdal Medical AS | 2025-11-24 | 180 | 0 |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024-06-25 | 347 | 0 |
| K183348 | Reusable Silicone Cover CPRmeter 2 | Laerdal Medical AS | 2018-12-17 | 14 | 0 |
| K173886 | CPRmeter 2 CPR Feedback Device | Laerdal Medical AS | 2018-03-23 | 92 | 0 |
| K151702 | Reusable Full Silicone Cover | Laerdal Medical AS | 2015-08-13 | 50 | 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