Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kermath Mfg. Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
111 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870221 | T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) | Kermath Mfg. Corp. | 1987-05-12 | 111 | 0 |
| K812726 | KERMATH THERAPY SIMULATOR | Kermath Mfg. Corp. | 1981-11-05 | 38 | 0 |
| K812332 | KERMATH L/C ARM | Kermath Mfg. Corp. | 1981-09-16 | 29 | 0 |
| K811215 | KERMATH RADIOGRAPHIC HEAD STAND | Kermath Mfg. Corp. | 1981-06-12 | 39 | 0 |
| K771549 | VERSATOME | Kermath Mfg. Corp. | 1977-08-25 | 13 | 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