Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laerdal Mfg. Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
128 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902429 | MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE | Laerdal Mfg. Corp. | 1990-09-27 | 128 | 0 |
| K900169 | MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE | Laerdal Mfg. Corp. | 1990-01-26 | 14 | 0 |
| K885186 | HEARTSTART 2000 DEFIBRILLATION ELECTRODE | Laerdal Mfg. Corp. | 1989-02-23 | 71 | 0 |
| K883341 | HEARTSTART 1000 | Laerdal Mfg. Corp. | 1988-09-12 | 34 | 0 |
| K883344 | HEARTSTART 1000S | Laerdal Mfg. Corp. | 1988-09-12 | 34 | 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