FDA product code · General Hospital · Class 2
FXX: Mask, Surgical
FXX is FDA's product code for "Mask, Surgical": a Class 2 device classified under 21 CFR 878.4040, reviewed by the General Hospital panel.
510(k) review time for FXX
Across 391 510(k) clearances under FXX decided from 2018-01-01 to 2026-10-06, the median was 140 days from FDA receipt to decision. Half took between 91 and 218 days, and 80% were decided within 237 days. These are past clearances, not a forecast for a new submission.
| Fastest | 8 |
|---|---|
| 25th percentile | 91 |
| Median | 140 |
| 75th percentile | 218 |
| 80th percentile | 237 |
| 90th percentile | 294 |
| Slowest | 780 |
| Year | Median days | n |
|---|---|---|
| 2020 | 113 | 27 |
| 2021 | 162 | 218 |
| 2022 | 113 | 91 |
| 2023 | 139 | 22 |
| 2024 | 263 | 15 |
| 2025 | 123 | 6 |
| 2026 (to 10-06, partial) | 142 | 5 |
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.
FXX in the public FDA record
| 510(k) clearances, all years | 607 |
|---|---|
| Device recalls | 12 |
| Establishment listings | 627 |
| GUDID device identifiers | 2,280 |
Counts of records, not of devices or events. Adverse event reports for FXX 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 FXX
5 FDA recognized consensus standards cite FXX, among them ASTM F1862/F1862M-17; ASTM F2100-23; ASTM F2101-23. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 6-406 ASTM F1862/F1862M-17 — Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- 6-492 ASTM F2100-23 — Standard Specification for Performance of Materials Used in Medical Face Masks
- 6-493 ASTM F2101-23 — Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials Using a Biological Aerosol of Staphylococcus aureus
- 6-504 ASTM F1862/F1862M-24 — Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- 6-519 ASTM F2101-25 — Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials Using a Biological Aerosol of Staphylococcus aureus
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.