Sofradim Production: FDA clearances and approvals
Sofradim Production has 42 FDA 510(k) clearances (first 1999, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time: 77 days. Since 2017 its median was 91 days, against 96 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Sofradim Production.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 95 |
| 2013 | 1 | 55 |
| 2014 | 4 | 31 |
| 2015 | 2 | 118 |
| 2016 | 0 | — |
| 2017 | 1 | 225 |
| 2018 | 2 | 131 |
| 2019 | 1 | 91 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 80 |
| 2023 | 0 | — |
| 2024 | 2 | 126 |
| 2025 | 2 | 58 |
| 2026 | 1 | 162 |
Review time against the same product codes
Since 2017, Sofradim Production's cleared 510(k)s took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 36 | 36 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 | 2 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | 1 | 1 |
Review panels
Most recent Sofradim Production 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | FTL | 2026-05-21 | 162 |
| K250869 | Parietene Macroporous Mesh (PPM5050 ) | FTL | 2025-04-23 | 30 |
| K243315 | ProGrip Self-Gripping Polypropylene Mesh | FTL | 2025-01-17 | 87 |
| K233661 | Transorb Self-Gripping Resorbable Mesh | OWT | 2024-02-13 | 90 |
| K232373 | Progrip Self-Gripping Polypropylene Mesh | FTL | 2024-01-18 | 163 |
| K223218 | Parietene Macroporous Mesh | FTL | 2022-12-02 | 46 |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | FTL | 2022-06-22 | 113 |
| K192443 | Dextile Anatomical Mesh | FTL | 2019-12-06 | 91 |
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | FTL | 2018-03-09 | 85 |
| K172395 | Duatene bilayer mesh | FTL | 2018-02-01 | 177 |
32 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-02-23.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sofradim Production have?
Sofradim Production has 42 FDA 510(k) clearances (first 1999, latest 2026), across 5 product codes in 3 review panels.
How long does FDA take to clear Sofradim Production's 510(k)s?
The median time from FDA receipt to decision across Sofradim Production's cleared 510(k)s is 77 days. Since 2017: 91 days, versus 96 days for all cleared 510(k)s in the same product codes.
What devices does Sofradim Production make?
Its most frequent FDA product codes are FTL (Mesh, Surgical, Polymeric, 36); OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, 2); OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, 2).
Has Sofradim Production had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Sofradim Production; the most recent began 2018-02-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 42 Sofradim Production clearances with predicates and recalls
- Run predicate analysis for product code FTL, Sofradim Production's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.