Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAR — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
131 daysmedian FDA review time
360 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261484 | Tissue Approximation System | Tas Medical, Inc. | 2026-06-03 | 29 | 0 |
| K220980 | Tissue Approximation System (TAS) | Tas Medical, Inc. | 2023-07-05 | 457 | 1 |
| K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | 2022-03-31 | 202 | 0 |
| K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 | 127 | 0 |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020-05-29 | 268 | 0 |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | 2017-03-02 | 262 | 0 |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016-02-17 | 292 | 0 |
| K152795 | RiverLon (Nylon) Suture | Riverpoint Medical | 2015-10-28 | 30 | 0 |
| K123034 | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | Unilene Sac | 2013-05-28 | 242 | 0 |
| K081366 | KUMAR T-ANCHORS HERNIA SET | Nashville Surgical Instruments | 2008-07-15 | 61 | 0 |
| K060471 | FSSB NYLON SURGICAL SUTURES | Fssb Chirurgische Nadeln GmbH | 2006-07-26 | 153 | 0 |
| K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | Mani, Inc. | 2006-05-19 | 141 | 0 |
| K060528 | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGIC | Aesculap, Inc. | 2006-03-28 | 28 | 0 |
| K052900 | QUILL NONABSORBABLE NYLON BARBED SUTURE | Quill Medical, Inc. | 2005-11-28 | 45 | 0 |
| K052482 | ARTELON SURGICAL SUTURE | Artimplant AB | 2005-10-17 | 38 | 0 |
| K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | Sutures India Private Limited | 2005-06-02 | 360 | 0 |
| K042284 | UNIMIDE | United Medical Industries Co. , Ltd. | 2004-12-03 | 101 | 0 |
| K042367 | NYLON THREADED NEEDLE | Aros Surgical Instruments Corp. | 2004-10-14 | 44 | 0 |
| K032160 | ARTELON SURGICAL SUTURE | Artimplant AB | 2003-11-17 | 125 | 0 |
| K031531 | S&T MICROSURGICAL SUTURE | S & T AG | 2003-09-23 | 131 | 0 |
| K030177 | ORLON NONABSORABLE SURGICAL SUTURE USP | Sri Orion Pharmaceuticals & Sutures | 2003-07-21 | 185 | 0 |
| K023028 | DEMETECH NYLON NONABSORBABLE SUTURE | Demetech Corp. | 2003-06-18 | 280 | 0 |
| K024090 | NYLON SUTURE | Aurolab | 2003-02-28 | 79 | 0 |
| K020146 | SERRALNYL | Serral, S.A. DE C.V. | 2002-04-15 | 89 | 0 |
| K003000 | GRAMS NYLON NONABSORBABLE SUTURE | Gramsmed, LLC | 2000-12-18 | 83 | 0 |
| K001173 | NYLON, NONABSORBABLE SURGICAL SUTURES USP | Cp Medical | 2000-06-23 | 73 | 1 |
| K000539 | NYLON NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-27 | 70 | 0 |
| K993970 | MICRINS MICROSURGICAL SUTURE | Micrins Surgical, Inc. | 2000-03-30 | 128 | 0 |
| K994176 | SUTRALON NYLON SUTURES | Visionary Medical Supplies, Inc. | 2000-02-08 | 60 | 0 |
| K993998 | NYLON | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | 72 | 0 |
| K990090 | DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | 1999-03-22 | 70 | 1 |
| K981582 | SURGILON, DERMALON, & OPHTHALON | Davis & Geck, Inc. | 1998-07-13 | 70 | 9 |
| K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-07-07 | 88 | 0 |
| K960327 | NYLON NOABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-03-04 | 40 | 0 |
| K943216 | SURGIDEK | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943223 | SURGIDEK B | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K943222 | SURGIDEK S | Sutures , Ltd. | 1994-12-05 | 153 | 0 |
| K931914 | SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE | Surgimetrics International, Ltd. | 1994-10-05 | 537 | 0 |
| K932037 | SUTURE ABSORBABLE- GUT | Surgical Specialties, Inc. | 1994-01-07 | 255 | 0 |
| K930943 | LUKENS NYLON SURGICAL SUTURE | Lukens Medical Corp. | 1993-12-17 | 297 | 0 |
| K931612 | NYLAMID SUTURE | S. Jackson, Inc. | 1993-12-17 | 260 | 0 |
| K930586 | DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT | Davis & Geck, Inc. | 1993-12-17 | 316 | 0 |
| K930517 | NON-ABSORBABLE SURGICAL SUTURES | Alcon Laboratories | 1993-12-17 | 319 | 0 |
| K931613 | SUPRAMID SUTURE | S. Jackson, Inc. | 1993-12-17 | 260 | 0 |
| K926168 | SILK SUTURES-REVISED LABELING | Look, Inc. | 1993-12-17 | 381 | 0 |
| K926587 | REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) | Look, Inc. | 1993-12-17 | 381 | 0 |
| K922530 | VISITEC MICROSURGICAL SUTURE | Visitec Co. | 1992-10-20 | 145 | 0 |
| K920510 | URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER | Uresil Corp. | 1992-09-14 | 225 | 0 |
| K913102 | PETERS CARDIONYL(TM) SUTURE | Promedica Products, Inc. | 1992-08-03 | 388 | 0 |
| K912429 | N80-838 SUPRAMID EXTRA SUTURE | S. Jackson, Inc. | 1991-10-02 | 124 | 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