Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KOQ — 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) |
|---|---|---|---|---|---|
| K901882 | URESIL ENDOSCOPIC LASER OVERTUBE | Uresil Corp. | 1990-07-27 | 92 | 0 |
| K900401 | NAS&P GRASPING FORCEPS & ASSOC. DEVICES | North American Sterilization & Packaging Co. | 1990-02-09 | 11 | 0 |
| K896821 | OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE | North American Sterilization & Packaging Co. | 1990-02-09 | 67 | 0 |
| K831265 | DENTOLOCK DENTURE ADHESIVE CREAM | Solar Dental Co., Inc. | 1983-05-09 | 21 | 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