Product code FTL: 510(k) clearances and predicates
Product code FTL covers ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030). FDA lists 336 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
336 clearances on file under product code FTL. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 6 |
| 2026 so far | 1 |
Recent clearances
Newest FTL clearances in the FDA index, with applicant and decision date:
- K253956, ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030), applicant Sofradim Production, decided 2026-05-21. FDA record
- K253125, Parietene Flat Sheet Mesh, applicant Medtronic - Sofradim Production, decided 2025-10-24. FDA record
- K251955, Onflex Mesh, applicant Davol Inc., Subsidiary of C. R. Bard, Inc., decided 2025-07-24. FDA record
- K251557, Bard® Mesh; Bard® Mesh Pre-Shaped, applicant Davol, Inc., decided 2025-06-12. FDA record
- K250869, Parietene Macroporous Mesh (PPM5050 ), applicant Sofradim Production, decided 2025-04-23. FDA record
- K250098, Bard Soft Mesh; Bard Soft Mesh Pre-Shaped, applicant Davol, Inc., decided 2025-04-09. FDA record
- K243315, ProGrip Self-Gripping Polypropylene Mesh, applicant Sofradim Production, decided 2025-01-17. FDA record
- K241250, 3DMax Light Mesh, applicant Davol Inc., Subsidiary of C. R. Bard, Inc., decided 2024-06-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Parietene Flat Sheet Mesh, Onflex Mesh. Watch new FTL clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FTL?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FTL clearances include ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030).
How many 510(k) clearances use product code FTL?
336 at the time this page was generated, from openFDA records.
How do I find a predicate device under FTL?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FTL clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.