Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Malibu Laboratories — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800022 | MODEL 807 SUCTION CAUTERY FINGER TIP | Malibu Laboratories | 1980-02-11 | 35 | 0 |
| K792150 | MODEL 808 ADAPTER | Malibu Laboratories | 1979-12-06 | 45 | 0 |
| K791224 | MALIBU LABS MODEL 800 FINGER TIP CONT | Malibu Laboratories | 1979-08-10 | 39 | 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