Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAS — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
397 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 | Lsi Solutions, Inc. | 2020-11-24 | 39 | 0 |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK | Lsi Solutions | 2020-11-24 | 42 | 0 |
| K091018 | ARTHREX BIOWIRE | Arthrex, Inc. | 2010-07-30 | 477 | 0 |
| K002261 | MR-III | Smith & Nephew, Inc. | 2000-10-23 | 90 | 0 |
| K953128 | SUTURE CORD | Phoenix Biomedical Corp. | 1996-02-09 | 218 | 0 |
| K923161 | BRAIDED POLYESTER SUTURE MATERIAL | Mitek Surgical Products, Inc. | 1992-12-30 | 184 | 0 |
| K913101 | PETERS CARDIOFLON(TM) SUTURE | Promedica Products, Inc. | 1992-08-12 | 397 | 0 |
| K915089 | MITEK QUICKANCHOR(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-02-03 | 83 | 0 |
| K915081 | MITEK SNAP PAK(TM), MODIFICATION | Mitek Surgical Products, Inc. | 1992-01-31 | 80 | 0 |
| K903175 | ADVANCE SUTURE NONABSORBABLE DACRON SUTURE | Advance Suture, Inc. | 1991-07-26 | 373 | 0 |
| K905285 | IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-02-11 | 77 | 0 |
| K905440 | FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | 1991-01-31 | 58 | 0 |
| K904535 | LU-TEX II | Lukens Medical Corp. | 1991-01-30 | 118 | 0 |
| K904436 | QUICKANCHOR (TM) | Mitek Surgical Products, Inc. | 1990-12-11 | 74 | 0 |
| K904263 | DACRON R SURGICAL SUTURES | Sharppoint, Inc. | 1990-10-16 | 29 | 0 |
| K904054 | POLYVIOLENE(TM) SUTURE | Look, Inc. | 1990-10-03 | 64 | 0 |
| K902873 | NONABSORBABLE DACRON SURGICAL SUTURE* | United States Surgical, A Division of Tyco Healthc | 1990-09-27 | 90 | 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