510(k) Review Times and Product Code
Researched with the BEUDAMED Research Assistant on July 11, 2026. Answers are generated from the BEUDAMED database and cite their records — verify time-critical facts against official sources.
For FDA surgical masks, the applicable product code is FXX — “Mask, Surgical”. The database classifies it as Class II under 21 CFR 878.4040. FXX classification
510(k) review duration: across 607 FXX clearances, the median review time is 128 days. FXX review-time analysis
Recent FXX examples show substantial variability:
| 510(k) | Device | Review time |
|---|---|---|
| K252964 | PRIMED Surgical and Procedure Masks | 48 days |
| K242502 | Aurelia Surgical Mask ASTM Level-3 | 82 days |
| K252941 | HALYARD Adult Face Mask | 87 days |
| K252830 | Disposable Surgical Face Mask | 129 days |
| K250082 | Procedure/Surgical/Face Mask | 156 days |
| K240916 | Surgical Face Mask | 198 days |
| K251967 | HALYARD FLUIDSHIELD procedure mask | 265 days |
| K243342 | KP Protective Face Mask | 423 days |
So, as a data-based planning reference—not a prediction—a roughly 4-month median is supported by the full FXX dataset, while recent decisions span from about 7 weeks to well over a year. FDA data are periodically imported and may lag the official source; confirm time-critical information at the FDA links on the individual records.
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