Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Humboldt Products — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
158 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832540 | DRUMTO STAPES PROSTHESIS | Humboldt Products | 1984-01-03 | 158 | 0 |
| K823483 | STAINLESS STEEL PISTONS | Humboldt Products | 1982-12-09 | 16 | 0 |
| K813616 | TEKNA MED MYRINGOTOMY DISPOS-OTO KIT | Humboldt Products | 1982-01-22 | 24 | 0 |
| K812562 | SURGICAL RETRACTOR & ELASTIC STAYS, DISP | Humboldt Products | 1981-10-02 | 24 | 0 |
| K802587 | OTOLOGICAL VENTILATION TUBES | Humboldt Products | 1980-11-12 | 23 | 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