Product code FXX: 510(k) clearances and predicates
Product code FXX covers 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. FDA lists 607 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
607 clearances on file under product code FXX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 91 |
| 2023 | 22 |
| 2024 | 15 |
| 2025 | 6 |
| 2026 so far | 5 |
Recent clearances
Newest FXX clearances in the FDA index, with applicant and decision date:
- K251967, 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, applicant O&M Halyard, Inc., decided 2026-03-18. FDA record
- K252534, Surgical Face Mask (Ear mount), applicant Zhejiang Hangkang Medical Equipment Co., Ltd., decided 2026-03-03. FDA record
- K253398, Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300), applicant Efofex, Inc., decided 2026-02-19. FDA record
- K252830, Disposable Surgical Face Mask (3P00B, C2900), applicant Beatles Medical Supplies (Xiantao) Co., Ltd., decided 2026-01-12. FDA record
- K252650, Disposable Medical Face Mask, applicant Makrite Industries, Inc., decided 2026-01-05. FDA record
- K243342, KP Protective Face Mask, applicant Kp Trading Co., Ltd., decided 2025-12-22. FDA record
- K252941, HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops, applicant O&M Halyard, Inc., decided 2025-12-11. FDA record
- K252964, PRIMED Surgical and Procedure Masks, applicant Primed Medical Products, Inc., decided 2025-11-04. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Surgical Face Mask (Ear mount), Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300). Watch new FXX clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FXX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FXX clearances include 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.
How many 510(k) clearances use product code FXX?
607 at the time this page was generated, from openFDA records.
How do I find a predicate device under FXX?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FXX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.