Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DSS · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
221 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983744 | MCAS (MODULAR CLIP APPLIER SYSTEM) | Applied Medical Resources | 1999-01-21 | 90 | 0 |
| K961333 | HEARTPORT MULTIFIRE CLIP APPLIER | Heartport, Inc. | 1996-11-15 | 221 | 0 |
| K920104 | IDENTI LOOPS DEGANIA SILICONE | Puritas Health Care, Inc. | 1992-04-20 | 102 | 0 |
| K920676 | RMI SOFCLAMP | Research Medical, Inc. | 1992-04-15 | 61 | 0 |
| K914523 | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | Catheter Research C/O Burditt, Bowles & Radzius | 1992-01-10 | 92 | 0 |
| K901303 | HORIZON SURGICAL LIGATING AND MARKING CLIP | Horizon Surgical, Inc. | 1990-06-05 | 77 | 0 |
| K883909 | SURGICAL SPRING CLIPS | Applied Vascular Devices, Inc. | 1988-12-27 | 103 | 0 |
| K771021 | AUTO-CLIP | Axiom Medical, Inc. | 1977-06-14 | 8 | 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