FDA product code FXX: Mask, Surgical
FXX is the FDA product code for mask, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 607 510(k) submissions under FXX, 139 in the last five years, from 468 different applicants. The average 510(k) review took 155 days (median 128); 192 days on average over the last three years. FDA has posted 12 recalls for FXX devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mask, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FXX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 117 |
| 2018 | 3 | 144 |
| 2019 | 4 | 150 |
| 2020 | 27 | 104 |
| 2021 | 218 | 169 |
| 2022 | 91 | 166 |
| 2023 | 22 | 174 |
| 2024 | 15 | 227 |
| 2025 | 6 | 175 |
| 2026 | 5 | 175 |
Top FXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tecnol New Jersey Wound Care, Inc. | 11 | 1991-08-23 |
| Owens & Minor (O&M) Halyard, Inc. | 8 | 2025-05-30 |
| Protectaide, Inc. | 7 | 1994-10-18 |
| Anago, Inc. | 7 | 1991-11-07 |
| Guangdong Kingfa Sci. & Tech.Co., Ltd. | 6 | 2024-07-29 |
463 more applicants have FXX clearances. See the full list in Caduvo.
Most recent FXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251967 | O&M Halyard, Inc. | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | 2026-03-18 | 265 |
| K252534 | Zhejiang Hangkang Medical Equipment Co., Ltd. | Surgical Face Mask (Ear mount) | 2026-03-03 | 203 |
| K253398 | Efofex, Inc. | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | 2026-02-19 | 142 |
| K252830 | Beatles Medical Supplies (Xiantao) Co., Ltd. | Disposable Surgical Face Mask (3P00B, C2900) | 2026-01-12 | 129 |
| K252650 | Makrite Industries, Inc. | Disposable Medical Face Mask | 2026-01-05 | 136 |
Recalls for FXX devices
12 product recalls in 7 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2024-11-08.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2023 | 4 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code FXX?
FXX is the FDA product code for mask, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FXX?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code FXX?
Across 607 cleared submissions the average was 155 days from receipt to decision (median 128).
Which companies have the most FXX clearances?
Tecnol New Jersey Wound Care, Inc. (11); Owens & Minor (O&M) Halyard, Inc. (8); Protectaide, Inc. (7); Anago, Inc. (7); Guangdong Kingfa Sci. & Tech.Co., Ltd. (6).
Have FXX devices been recalled?
Yes: 12 product recalls across 7 recall events; the most recent began 2024-11-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FXX
- Run a recall and safety report across every FXX manufacturer
- Watch product code FXX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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