Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Combe, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
162 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942203 | OTC DENTURE CLEANSER | Combe, Inc. | 1994-08-10 | 97 | 0 |
| K925259 | CFR MONOGRAPH | Combe, Inc. | 1993-01-11 | 84 | 0 |
| K863375 | SEA-BOND | Combe, Inc. | 1986-09-19 | 16 | 0 |
| K780719 | FUNGUS FIGHTER INSOLES | Combe, Inc. | 1978-10-10 | 162 | 0 |
| K770413 | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | Combe, Inc. | 1977-06-24 | 112 | 0 |
| K770175 | SEA-BOND ADHEVISE DENTURE CUSHIONS | Combe, Inc. | 1977-02-04 | 9 | 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