Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laerdal Medical Corp. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
205 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001742 | RESUSCI INFLATE-A-SHIELD CPR BARRIER | Laerdal Medical Corp. | 2000-10-06 | 120 | 0 |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | Laerdal Medical Corp. | 1996-09-05 | 78 | 0 |
| K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION | Laerdal Medical Corp. | 1996-05-09 | 205 | 0 |
| K954609 | HEARTSTART 911 | Laerdal Medical Corp. | 1996-01-04 | 92 | 0 |
| K950698 | LSU 2000 PORTABLE SUCTION UNIT | Laerdal Medical Corp. | 1995-05-09 | 88 | 0 |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | Laerdal Medical Corp. | 1993-12-02 | 205 | 0 |
| K896919 | HEARTSTART 3000 | Laerdal Medical Corp. | 1990-05-03 | 142 | 0 |
| K880450 | RESUSCI PATIENT FACE SHIELD | Laerdal Medical Corp. | 1988-03-04 | 31 | 0 |
| K861401 | LAERDAL POCKET MASK | Laerdal Medical Corp. | 1986-05-21 | 36 | 0 |
| K840110 | LAERDAL SUCTION UNIT | Laerdal Medical Corp. | 1984-03-12 | 62 | 0 |
| K822356 | MODULAIDE EMERG. CARDIAC LIFE SUPP. KT | Laerdal Medical Corp. | 1982-08-20 | 14 | 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