Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laerdal California, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
189 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941578 | STATVAC PORTABLE SUCTION UNIT | Laerdal California, Inc. | 1994-05-18 | 48 | 0 |
| K922842 | STYLET AND TRACHEAL LIGHTWAND (STL) | Laerdal California, Inc. | 1992-12-18 | 189 | 0 |
| K862875 | E-VAC(TM) | Laerdal California, Inc. | 1986-11-03 | 96 | 0 |
| K843790 | TRACHEAL TUBE FIXATION DEVICE | Laerdal California, Inc. | 1985-03-11 | 165 | 0 |
| K832990 | STIFNICK IMMOBILIZING COLLAR | Laerdal California, Inc. | 1983-11-07 | 67 | 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