Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAQ — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
139 daysmedian FDA review time
305 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203855 | CoNextions TR Tendon Repair System | Conextions Medical | 2022-04-22 | 477 | 0 |
| K193209 | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | 2020-02-19 | 90 | 0 |
| K172146 | MERISTEEL | M/s. Meril Endo Surgery Private Limited. | 2018-02-01 | 199 | 0 |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. | 2017-11-01 | 232 | 0 |
| K141007 | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | Demetech Corp. | 2014-09-25 | 160 | 0 |
| K140127 | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP | Pontis Orthopaedics, LLC | 2014-05-28 | 132 | 0 |
| K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES ( | Core Essence Orthopaedics, LLC | 2008-12-24 | 254 | 0 |
| K082828 | SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE | Suturtek Incorporated | 2008-10-14 | 19 | 0 |
| K063603 | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S1 | Suturtek Incorporated | 2007-02-07 | 66 | 0 |
| K042606 | MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | 2005-05-27 | 245 | 0 |
| K041333 | SYNTHES (USA) TITANIUM WIRE | Synthes (Usa) | 2004-08-27 | 100 | 0 |
| K032468 | SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE | Suturtek Incorporated | 2003-09-23 | 43 | 0 |
| K023594 | TENO FIX | Ortheon Medical, LLC | 2003-05-15 | 202 | 0 |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Cp Medical | 2003-03-28 | 53 | 0 |
| K023411 | STEELEX STERNUM SET | Aesculap, Inc. | 2002-12-19 | 69 | 0 |
| K022777 | MANUAL TOUCHE SYSTEM | Onux Medical, Inc. | 2002-11-19 | 90 | 0 |
| K013059 | STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES | Stony Brook Surgical Innovations, Inc. | 2001-10-22 | 41 | 0 |
| K991073 | ACIER SUTURES | Cardio Thoracic Systems | 1999-07-30 | 121 | 0 |
| K984151 | STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP | Mill Pond, Inc. | 1999-04-28 | 160 | 0 |
| K955723 | STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS) | Davis & Geck, Inc. | 1996-02-27 | 71 | 0 |
| K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, | ETHICON, Inc. | 1995-01-09 | 21 | 4 |
| K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL | Deknatel, Inc. | 1994-07-26 | 529 | 1 |
| K931915 | STAINLESS STEEL SUTURE | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 0 |
| K931271 | ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE | ETHICON, Inc. | 1994-01-07 | 305 | 0 |
| K933686 | LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE | Look, Inc. | 1993-12-23 | 147 | 0 |
| K930992 | FLEXON AND STAINLESS STEEL SUTURES | American Cyanamid Co. | 1993-12-17 | 295 | 0 |
| K930940 | LUKENS STAINLESS STEEL SURGICAL SUTURE | Lukens Medical Corp. | 1993-12-17 | 297 | 0 |
| K913185 | STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT | Internacional Farmaceutica, S.A. DE C.V. | 1991-12-04 | 139 | 0 |
| K913155 | LEG URINAL | Ezmt Valve Co., Inc. | 1991-09-16 | 61 | 0 |
| K910067 | PTI STERNAL CLOSURE WIRE SUTURE | Pioneering Technologies, Inc. | 1991-05-06 | 117 | 0 |
| K873645 | STAINLESS 22-13-5 SUTURE WIRE | Zimmer, Inc. | 1987-11-17 | 70 | 0 |
| K865038 | SURGISTEEL | Sutures , Ltd. | 1987-06-30 | 188 | 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