Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GAP — Predicate Candidate Screening
41 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
324 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241486 | Sofsilk™ Coated Braided Silk Suture | Covidien | 2024-12-03 | 193 | 0 |
| K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing Sy | Safepath Medical, Inc. | 2024-10-18 | 753 | 0 |
| K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | 2024-01-16 | 162 | 0 |
| K221767 | Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. | 2023-07-31 | 409 | 0 |
| K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018-06-25 | 101 | 0 |
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILA | M/s. Meril Endo Surgery Private Limited. | 2017-10-20 | 95 | 0 |
| K162396 | SILK Surgical Suture | Teleflexmedical, Inc. | 2016-11-23 | 89 | 0 |
| K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILA | M/s. Meril Endo Surgery Private Limited. | 2016-05-31 | 88 | 0 |
| K080684 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | 2008-06-09 | 91 | 0 |
| K071111 | NON-ABSORBABLE SILK SUTURE | Arrow Intl., Inc. | 2007-07-17 | 88 | 0 |
| K053638 | MANI NEEDLE & SUTURE PACK (SILK) | Mani, Inc. | 2006-05-19 | 141 | 0 |
| K041514 | TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE | Sutures India Private Limited | 2005-06-03 | 361 | 0 |
| K042282 | UNISILK | United Medical Industries Co. , Ltd. | 2004-12-01 | 99 | 0 |
| K024091 | SILK SUTURES | Aurolab | 2003-02-28 | 79 | 0 |
| K023029 | DEMETECH SILK NONABSORBABLE SUTURE | Demetech Corp. | 2002-11-25 | 75 | 0 |
| K020901 | SERRALSILK | Serral, S.A. DE C.V. | 2002-04-26 | 37 | 0 |
| K012124 | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP | Johnson & Johnson Medical (China) , Ltd. | 2001-09-19 | 75 | 0 |
| K003001 | GRAMS SILK NONABSORBABLE SUTURE | Gramsmed, LLC | 2000-12-15 | 80 | 0 |
| K001184 | SILK, NONABSORBABLE, SURGICAL SUTURES, USP | Cp Medical | 2000-06-23 | 73 | 0 |
| K000541 | SILK NONABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 | 71 | 0 |
| K994177 | SUTRASILK SILK SUTURE | Visionary Medical Supplies, Inc. | 2000-02-08 | 60 | 0 |
| K993999 | SILK | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | 72 | 0 |
| K982853 | SILK SUTURE | Davis & Geck, Inc. | 1999-04-30 | 260 | 0 |
| K990089 | SILKAM NONABSORBABLE SILK SURGICAL SUTURE | Aesculap, Inc. | 1999-03-15 | 63 | 0 |
| K981128 | SOFSILK SUTURE | United States Surgical, A Division of Tyco Healthc | 1998-05-11 | 42 | 13 |
| K980124 | SOFSILK SUTURE | United States Surgical, A Division of Tyco Healthc | 1998-03-27 | 72 | 0 |
| K964581 | SOFSILK | United States Surgical, A Division of Tyco Healthc | 1997-01-16 | 62 | 0 |
| K960328 | SILK NONABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-03-04 | 40 | 0 |
| K943627 | SURGISILK | Sutures , Ltd. | 1994-12-05 | 132 | 0 |
| K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK | Deknatel, Inc. | 1994-07-26 | 529 | 1 |
| K942234 | VISITEC PRECISE-POINT | Visitec Co. | 1994-07-12 | 64 | 0 |
| K931913 | SUTURE NON-ABSORBABLE SILK | Surgimetrics International, Ltd. | 1994-03-03 | 321 | 0 |
| K930826 | SUTURE NONABSORBABLE - SILK | Surgical Specialties, Inc. | 1994-01-07 | 324 | 0 |
| K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | Surgical Specialties, Inc. | 1994-01-07 | 324 | 1 |
| K905454 | ADVANCE SUTURE NONABSORBABLE SILK SUTURE | Advance Suture, Inc. | 1991-06-28 | 205 | 0 |
| K905287 | IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-02-11 | 77 | 0 |
| K904478 | NONABSORBABLE SILK SURGICAL SUTURE | United States Surgical, A Division of Tyco Healthc | 1990-11-14 | 47 | 0 |
| K904891 | NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE) | United States Surgical, A Division of Tyco Healthc | 1990-11-14 | 15 | 0 |
| K761199 | AIRWAY PRESSURE MONITOR | Draeger Medical, Inc. | 1977-02-28 | 84 | 0 |
| K760650 | RETRACTOR, GERBODE STERNAL | Dilling Co. | 1976-09-21 | 6 | 0 |
| K760158 | NEEDLES AND SUTURES, SILK & NYLON | Alcon Laboratories | 1976-08-19 | 48 | 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