Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FTL — Predicate Candidate Screening
336 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
252 days90th percentile
336clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, | Sofradim Production | 2026-05-21 | 162 | 0 |
| K253125 | Parietene™ Flat Sheet Mesh | Medtronic - Sofradim Production | 2025-10-24 | 29 | 0 |
| K251955 | Onflex™ Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025-07-24 | 29 | 0 |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | 2025-06-12 | 22 | 0 |
| K250869 | Parietene™ Macroporous Mesh (PPM5050 ) | Sofradim Production | 2025-04-23 | 30 | 0 |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | 2025-04-09 | 85 | 0 |
| K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2025-01-17 | 87 | 0 |
| K241250 | 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2024-06-14 | 42 | 0 |
| K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2024-01-18 | 163 | 0 |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2023-11-01 | 28 | 0 |
| K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-10-18 | 29 | 0 |
| K230671 | Pitch PaSoft Tissue Reinforcement Device | Xiros, Ltd. | 2023-05-31 | 82 | 0 |
| K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023-02-23 | 27 | 0 |
| K223218 | Parietene Macroporous Mesh | Sofradim Production | 2022-12-02 | 46 | 0 |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2022-11-28 | 181 | 0 |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | Covidien | 2022-09-22 | 209 | 0 |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022-08-26 | 226 | 0 |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mes | Sofradim Production | 2022-06-22 | 113 | 0 |
| K211132 | ARISTE AB Mesh | Ariste Medical, LLC | 2022-03-18 | 336 | 0 |
| K211563 | Pitch-Patchs | Xiros, Ltd. | 2021-08-13 | 85 | 0 |
| K200918 | SurgiWrap FROST | Mast Biosurgery | 2021-01-07 | 276 | 0 |
| K201143 | VICRYL Mesh | ETHICON, Inc. | 2020-08-06 | 99 | 0 |
| K200818 | 3DMax MID Anatomical Mesh | C.R. Bard, Inc. | 2020-07-17 | 109 | 0 |
| K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX | Medtronic, Inc. | 2020-04-08 | 198 | 0 |
| K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2020-03-30 | 138 | 0 |
| K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorb | Medtronic, Inc. | 2020-03-27 | 206 | 0 |
| K192443 | Dextile Anatomical Mesh | Sofradim Production | 2019-12-06 | 91 | 0 |
| K191373 | VICRYL Mesh | ETHICON, Inc. | 2019-10-22 | 152 | 0 |
| K192112 | FlexBand Plus | International Life Sciences | 2019-09-27 | 53 | 0 |
| K191545 | Exogenesis Hernia Mesh | Exogenesis Corporation | 2019-09-26 | 107 | 0 |
| K182008 | Phasix ST Mesh with Echo 2 Positioning System | C.R. Bard, Inc. | 2018-12-14 | 140 | 0 |
| K181935 | Endoform Reconstructive Template - Non Absorbable | Aroa Biosurgery , Ltd. | 2018-12-04 | 138 | 0 |
| K182087 | DynaMesh-POSTERIOR | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2018-10-31 | 90 | 0 |
| K181094 | Polydioxanone Surgical Scaffold | Lntegra Lifesciences | 2018-08-02 | 99 | 0 |
| K181268 | PROLENE (Polypropylene) 3D Patch | ETHICON, Inc. | 2018-07-26 | 73 | 0 |
| K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | ETHICON, Inc. | 2018-07-02 | 87 | 0 |
| K180829 | PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical | ETHICON, Inc. | 2018-06-28 | 90 | 0 |
| K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX | Medtronic, Inc. | 2018-06-07 | 142 | 0 |
| K172636 | VitaMESH Macroporous PP Surgical Mesh | Proxy Biomedical , Ltd. | 2018-04-30 | 241 | 0 |
| K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorb | Medtronic, Inc. | 2018-04-24 | 111 | 0 |
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2 | Sofradim Production | 2018-03-09 | 85 | 1 |
| K172395 | Duatene bilayer mesh | Sofradim Production | 2018-02-01 | 177 | 0 |
| K172089 | PROLENE Soft Polypropylene Mesh | ETHICON, Inc. | 2017-10-05 | 86 | 0 |
| K170134 | Reperen Surgical Mesh | Iconlab, Inc. | 2017-08-09 | 204 | 0 |
| K163212 | Parietene DS Composite Mesh | Sofradim Production | 2017-06-29 | 225 | 0 |
| K163576 | GORE SYNECOR Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2017-05-11 | 143 | 0 |
| K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5 | C. R. Bard | 2017-05-01 | 90 | 0 |
| K163152 | PROLENE Soft Polypropylene Mesh | ETHICON, Inc. | 2017-03-11 | 121 | 0 |
| K161550 | DynaMesh-VENTRAL | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft | 2016-12-22 | 202 | 0 |
| K153632 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016-06-16 | 181 | 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