Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FDE · 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) |
|---|---|---|---|---|---|
| K955717 | ENDOSCOPE INTRODUCER KIT | Mitsubishi Cable America, Inc. | 1996-04-18 | 122 | 0 |
| K950924 | ASLAN KNOT PUSHER | Aslan Medical Technologies, Ltd. | 1995-03-14 | 13 | 0 |
| K942677 | GEENEN/ZEBRA GUIDELINES | Boston Scientific Corp | 1994-07-21 | 44 | 0 |
| K912443 | CANDELA INTRODUCER SHEATH SYSTEM | Candela Laser Corp. | 1991-08-16 | 74 | 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