Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KYP · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883839 | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 | Marlo Surgical Technology | 1988-12-09 | 88 | 0 |
| K844048 | DR. HESSEL'S INSECT POISON REMOVER | Medie Group | 1985-01-23 | 98 | 0 |
| K842015 | SAWYER FIRST AID KIT | Saffeta, Inc. | 1984-07-06 | 49 | 0 |
| K831312 | LOPEZ-HORN CARRIER | Chiron Vision Corp. | 1983-05-25 | 33 | 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