Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NEW — Predicate Candidate Screening
65 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
337 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261988 | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic | Teleflex Medical, LLC | 2026-07-09 | 27 | 0 |
| K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | 2026-06-12 | 337 | 0 |
| K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devic | ETHICON, Inc. | 2026-05-18 | 322 | 0 |
| K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Ab | ETHICON, Inc. | 2025-11-12 | 328 | 0 |
| K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025-10-20 | 166 | 0 |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | 2025-10-15 | 273 | 0 |
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) | M/s. Meril Endo Surgery Private Limited. | 2025-09-23 | 33 | 0 |
| K250977 | Suture-TOOL System | Suturion AB | 2025-04-28 | 28 | 0 |
| K242835 | Suture-TOOL System | Suturion AB | 2025-01-22 | 125 | 0 |
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC | Hyundae Meditech Co., Ltd. | 2024-09-27 | 29 | 0 |
| K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanon | M/s. Meril Endo Surgery Private Limited. | 2024-04-25 | 272 | 0 |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL219 | Hyundae Meditech Co., Ltd. | 2024-03-27 | 48 | 0 |
| K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I S | Hans Biomed Corporation | 2023-03-07 | 375 | 0 |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Abs | ETHICON, Inc. | 2022-02-22 | 204 | 1 |
| K210871 | PDO Max Suture with Dual Needle | Pdo Max, Inc. | 2021-12-17 | 268 | 0 |
| K201139 | WEGO-PDO Barbed Suture | Foosin Medical Supplies Inc., Ltd. | 2020-10-20 | 175 | 0 |
| K192423 | MINT Product Family | Hans Biomed Corporation | 2020-09-09 | 371 | 0 |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Cont | ETHICON, Inc. | 2020-03-25 | 230 | 1 |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | 2019-11-07 | 170 | 0 |
| K190264 | Viola | Meditime Co., Ltd. | 2019-08-15 | 188 | 0 |
| K190245 | PDS Barbed Suture, PDO MAXX Threads | Pdo Max, Inc. | 2019-06-04 | 118 | 0 |
| K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2019-01-10 | 90 | 5 |
| K172602 | Miracu | Feeltech Co., Ltd. | 2018-11-14 | 441 | 0 |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | 2018-08-27 | 73 | 0 |
| K162366 | Omega VL | Ov World Co., Ltd. | 2018-03-02 | 556 | 0 |
| K161737 | RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed | Myco Medical | 2017-03-02 | 252 | 0 |
| K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixati | Y. Jacobs Medical, Inc. | 2016-11-23 | 254 | 0 |
| K160761 | DW-1C | Dongwon Medical Co., Ltd. | 2016-11-22 | 246 | 0 |
| K150553 | Filbloc | Assut Europe | 2016-05-19 | 442 | 0 |
| K143413 | J+PRAS YOUNG'S Thread | Y. Jacobs Medical, Inc. | 2015-09-11 | 287 | 0 |
| K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015-07-02 | 108 | 0 |
| K141776 | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES | ETHICON, Inc. | 2014-10-15 | 105 | 0 |
| K133420 | TRANQUILL BARBED DEVICE | Surgical Specialties Corp. Dba Angiotech | 2013-11-29 | 21 | 0 |
| K132268 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESI | Surgical Specialties Corporation Dba Angiotech | 2013-08-23 | 32 | 0 |
| K130191 | MINT | Hans Biomed Corporation | 2013-06-12 | 138 | 0 |
| K123668 | ORTHOCORD | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013-02-26 | 89 | 0 |
| K123877 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESI | Surgical Specialties Corp. Dba Angiotech | 2013-01-02 | 16 | 0 |
| K120827 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) | Angiotech | 2012-07-13 | 116 | 0 |
| K120284 | DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE | Coloplast A/S | 2012-05-23 | 113 | 1 |
| K113744 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) | Angiotech | 2012-02-01 | 43 | 0 |
| K113004 | PDS(TM) BARBED SUTURES | ETHICON, Inc. | 2011-12-20 | 74 | 1 |
| K100780 | VITAL SUTURES, SUTUREX, CIRUGIA PERUANA | Unilene Sac | 2010-12-14 | 270 | 0 |
| K100461 | PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT | Riverpoint Medical | 2010-07-08 | 140 | 1 |
| K082097 | DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBAB | Demetech Corp. | 2010-01-08 | 533 | 0 |
| K081001 | PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE | Sutures India Pvt., Ltd. | 2008-06-09 | 62 | 0 |
| K073614 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | 2008-04-30 | 126 | 0 |
| K080918 | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENI | Depuy Mitek | 2008-04-23 | 22 | 0 |
| K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE | Surgical Specialties Corp | 2008-04-23 | 16 | 0 |
| K080680 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOX | Surgical Specialties Corp | 2008-03-21 | 11 | 0 |
| K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGI | Surgical Specialties Corp | 2007-08-06 | 17 | 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