FDA product code · General Hospital · Class 2
FYA: Gown, Surgical
FYA is FDA's product code for "Gown, Surgical": a Class 2 device classified under 21 CFR 878.4040, reviewed by the General Hospital panel.
510(k) review time for FYA
Across 85 510(k) clearances under FYA decided from 2018-01-01 to 2026-10-06, the median was 170 days from FDA receipt to decision. Half took between 109 and 262 days, and 80% were decided within 282 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 109 |
| Median | 170 |
| 75th percentile | 262 |
| 80th percentile | 282 |
| 90th percentile | 393 |
| Slowest | 659 |
| Year | Median days | n |
|---|---|---|
| 2019 | 105 | 5 |
| 2020 | 114 | 7 |
| 2021 | 163 | 17 |
| 2022 | 177 | 24 |
| 2023 | 190 | 12 |
| 2024 | 163 | 5 |
| 2026 (to 10-06, partial) | 198 | 9 |
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.
FYA in the public FDA record
| 510(k) clearances, all years | 298 |
|---|---|
| Device recalls | 129 |
| Establishment listings | 732 |
| GUDID device identifiers | 2,885 |
Counts of records, not of devices or events. Adverse event reports for FYA 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 FYA
6 FDA recognized consensus standards cite FYA, 4 of them recognized only in part, among them ANSI AAMI ST65:2008/(R)2018; ASTM F2407-20; ANSI AAMI PB70:2022. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 14-286 ANSI AAMI ST65:2008/(R)2018 — Processing of reusable surgical textiles for use in health care facilities
- 6-448 ASTM F2407-20 (partial recognition) — Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
- 6-487 ANSI AAMI PB70:2022 (partial recognition) — Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
- 6-488 ASTM F1671/F1671M-22 — Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
- 6-496 ASTM F739-20 (partial recognition) — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
- 6-516 ASTM F2407/F2407M-23a (partial recognition) — Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.