Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Sofradim Production — Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
156 days90th percentile
42clearances 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 |
| K250869 | Parietene™ Macroporous Mesh (PPM5050 ) | Sofradim Production | 2025-04-23 | 30 | 0 |
| K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2025-01-17 | 87 | 0 |
| K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | 2024-02-13 | 90 | 0 |
| K232373 | Progrip™ Self-Gripping Polypropylene Mesh | Sofradim Production | 2024-01-18 | 163 | 0 |
| K223218 | Parietene Macroporous Mesh | Sofradim Production | 2022-12-02 | 46 | 0 |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mes | Sofradim Production | 2022-06-22 | 113 | 0 |
| K192443 | Dextile Anatomical Mesh | Sofradim Production | 2019-12-06 | 91 | 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 |
| K163212 | Parietene DS Composite Mesh | Sofradim Production | 2017-06-29 | 225 | 0 |
| K150091 | Versatex Monofilament Mesh | Sofradim Production | 2015-05-26 | 130 | 1 |
| K143386 | Progrip Laparoscopic Self-Fixating Mesh | Sofradim Production | 2015-03-13 | 107 | 0 |
| K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lig | Sofradim Production | 2014-11-14 | 39 | 0 |
| K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polye | Sofradim Production | 2014-10-28 | 22 | 0 |
| K142091 | PARIETENE MACROPOROUS MESH | Sofradim Production | 2014-10-17 | 77 | 0 |
| K140941 | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHE | Sofradim Production | 2014-05-07 | 23 | 0 |
| K131969 | SYMBOTEX(TM) COMPOSITE MESH | Sofradim Production | 2013-08-22 | 55 | 0 |
| K123479 | PROGRIP LAPAROSCOPIC SELF-FIXATING MESH | Sofradim Production | 2012-12-11 | 28 | 0 |
| K120897 | PROGRIP LAPARSCOPIC SELF-FIXATING MESH | Sofradim Production | 2012-06-29 | 95 | 0 |
| K120506 | PARIETEX COMPOSITE VENTRAL PATCH | Sofradim Production | 2012-06-13 | 113 | 0 |
| K110663 | PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) | Sofradim Production | 2011-08-11 | 156 | 0 |
| K110815 | PARIETEX OPTIMIZED COMPOSTIE MESH | Sofradim Production | 2011-04-19 | 26 | 0 |
| K110816 | PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) | Sofradim Production | 2011-04-19 | 26 | 0 |
| K103682 | PARIETEX PROGRIP | Sofradim Production | 2011-03-04 | 77 | 0 |
| K101519 | PARIETEX PLUG AND PATCH | Sofradim Production | 2010-11-05 | 156 | 0 |
| K101197 | PARIE TENE PROGRIP MESH | Sofradim Production | 2010-05-05 | 7 | 0 |
| K090858 | PARIETEX MONOFILAMENT POLYESTER MESH | Sofradim Production | 2009-05-06 | 37 | 0 |
| K081126 | PARIETEX COMPOSITE MONO PM MESH | Sofradim Production | 2008-08-13 | 114 | 0 |
| K081050 | PARIETEX PROGRIP MESH | Sofradim Production | 2008-05-28 | 44 | 0 |
| K073287 | PREVADH MESH | Sofradim Production | 2008-03-13 | 113 | 0 |
| K072951 | PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES | Sofradim Production | 2007-12-19 | 62 | 0 |
| K071629 | PARIETEX POLYESTER MESH WITH INTRODUCER | Sofradim Production | 2007-07-10 | 26 | 0 |
| K051503 | UGYTEX SUAL KNIT MESH | Sofradim Production | 2005-08-05 | 59 | 0 |
| K050187 | PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES | Sofradim Production | 2005-02-18 | 22 | 0 |
| K041176 | URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM | Sofradim Production | 2004-05-17 | 12 | 0 |
| K040998 | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH | Sofradim Production | 2004-04-29 | 10 | 0 |
| K033376 | UGYTEX MESH | Sofradim Production | 2004-01-15 | 85 | 0 |
| K032093 | PARIEFIX | Sofradim Production | 2003-10-22 | 107 | 0 |
| K012949 | URETEX SUP PUBOURETHRAL SLING | Sofradim Production | 2001-10-04 | 30 | 0 |
| K003990 | SOFRADIM PARIETEX SURGICAL MESHES | Sofradim Production | 2001-01-24 | 29 | 0 |
| K991400 | PARIETENE POLYPROPYLENE MESH | Sofradim Production | 1999-07-12 | 81 | 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