Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KCJ · 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) |
|---|---|---|---|---|---|
| K923679 | ENDOPATH TISSUE RETAINING COMPONENT | Ethicon Endo-Surgery, Inc. | 1992-09-09 | 49 | 0 |
| K921053 | LAPAROMED LIGATING LOOP | Laparomed Corp. | 1992-08-06 | 154 | 0 |
| K894369 | APDYNE PHENOL APPLICATOR KIT | Apdyne Medical Co. | 1989-10-12 | 90 | 0 |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Kells Medical, Inc. | 1983-09-29 | 51 | 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