Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laerdal Medical A/S · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132172 | NEONATALIE RESUSCITATOR | Laerdal Medical A/S | 2015-01-15 | 549 | 0 |
| K122050 | CPRMETER CPR FEEDBACK DEVICE | Laerdal Medical A/S | 2012-10-22 | 102 | 0 |
| K023805 | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 | Laerdal Medical A/S | 2003-02-11 | 89 | 0 |
| K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | Laerdal Medical A/S | 1999-12-20 | 49 | 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