Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KSK — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Gamma Biologicals, Inc. | 1982-03-04 | 99 | 0 |
| K813404 | FREEZE DRIED FICIN | Biological Corp. of America | 1982-02-10 | 65 | 0 |
| K810803 | FREEZE DRIED PAPAIN | Biological Corp. of America | 1981-07-21 | 119 | 0 |
| K780962 | AUTOMATED ENZYME | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 | 45 | 0 |
| K760123 | AUTOZYME | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 | 22 | 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