FDA product code · General, Plastic Surgery · Class 2
FTL: Mesh, Surgical, Polymeric
FTL is FDA's product code for "Mesh, Surgical, Polymeric": a Class 2 device classified under 21 CFR 878.3300, reviewed by the General, Plastic Surgery panel. FDA flags it as an implant.
510(k) review time for FTL
Across 42 510(k) clearances under FTL decided from 2018-01-01 to 2026-10-06, the median was 99 days from FDA receipt to decision. Half took between 75 and 160 days, and 80% were decided within 174 days. These are past clearances, not a forecast for a new submission.
| Fastest | 22 |
|---|---|
| 25th percentile | 75 |
| Median | 99 |
| 75th percentile | 160 |
| 80th percentile | 174 |
| 90th percentile | 209 |
| Slowest | 336 |
| Year | Median days | n |
|---|---|---|
| 2018 | 105 | 12 |
| 2020 | 138 | 5 |
| 2022 | 195 | 6 |
| 2025 | 30 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FTL in the public FDA record
| 510(k) clearances, all years | 336 |
|---|---|
| Device recalls | 73 |
| Establishment listings | 514 |
| GUDID device identifiers | 1,863 |
Counts of records, not of devices or events. Adverse event reports for FTL are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite FTL
3 FDA recognized consensus standards cite FTL, 1 of them recognized only in part, among them ASTM F881-94 (Reapproved 2022); ASTM F754-08 (Reapproved 2015); ASTM F754-24. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-185 ASTM F881-94 (Reapproved 2022) — Standard Specification for Silicone Elastomer Facial Implants
- 8-179 ASTM F754-08 (Reapproved 2015) (partial recognition) — Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet Tube and Rod Shapes Fabricated from Granular Molding Powders
- 8-628 ASTM F754-24 — Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet Tube and Rod Shapes Fabricated from Granular Molding Powders
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.