Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FXX — Predicate Candidate Screening
607 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
294 days90th percentile
607clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT | O&M Halyard, Inc. | 2026-03-18 | 265 | 0 |
| K252534 | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | 2026-03-03 | 203 | 0 |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | 2026-02-19 | 142 | 0 |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. | 2026-01-12 | 129 | 0 |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 2026-01-05 | 136 | 0 |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 2025-12-22 | 423 | 0 |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* E | O&M Halyard, Inc. | 2025-12-11 | 87 | 0 |
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | 2025-11-04 | 48 | 0 |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Pr | Vitacore Industries, Inc. | 2025-09-17 | 89 | 0 |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2025-06-18 | 156 | 0 |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti- | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 | 246 | 0 |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada – Supermax Medical | 2024-11-12 | 82 | 0 |
| K240916 | Surgical Face Mask (Tie on/ Ear loops) | Xiantao Daoqi Plastic Co., Ltd. | 2024-10-18 | 198 | 0 |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | 2024-08-26 | 207 | 0 |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 | 251 | 0 |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining | Owens & Minor (O&M) Halyard, Inc. | 2024-07-02 | 293 | 0 |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SO | Owens & Minor (O&M) Halyard, Inc. | 2024-07-01 | 294 | 0 |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SO | Owens & Minor (O&M) Halyard, Inc. | 2024-06-21 | 283 | 0 |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* | Owens & Minor (O&M) Halyard, Inc. | 2024-06-14 | 276 | 0 |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining a | Owens & Minor (O&M) Halyard, Inc. | 2024-06-07 | 269 | 0 |
| K232968 | Grande Medical Masks, Model SF-600 | Golden Grande Corp. | 2024-06-06 | 259 | 0 |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft | Owens & Minor (O&M) Halyard, Inc. | 2024-06-04 | 265 | 0 |
| K240258 | Disposable Medical Face Mask (M643BE) | Makrite Industries, Inc. | 2024-04-18 | 78 | 0 |
| K232112 | R&G Surgical Mask | R&G Seguridad E Higiene Industrial S.A.C. | 2024-04-02 | 263 | 0 |
| K231719 | Medical Surgical Mask | Azur Medical Company, Inc. | 2024-03-19 | 280 | 0 |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber | Owens & Minor (O&M) Halyard, Inc. | 2024-01-08 | 112 | 0 |
| K232797 | Hygenix | Shenzhen Hygenix Industrial Co., Ltd. | 2023-12-11 | 90 | 0 |
| K231005 | Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask AS | Supermax Healthcare Canada-Supermax Medical | 2023-12-05 | 242 | 0 |
| K231155 | Biodegradable Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-11-07 | 197 | 0 |
| K232359 | Surgical face mask | Kingstar Medical (Xianning) Co., Ltd. | 2023-10-02 | 56 | 0 |
| K230380 | Surgical Face Masks, Model: EFMDS-L50Pn BLU | Iris USA | 2023-08-03 | 171 | 0 |
| K231618 | 3 Layer Surgical Mask (134252531) | Original Mattress Factory, Inc. | 2023-07-28 | 56 | 0 |
| K230395 | Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 ( | Durio Ppe Sdn Bhd | 2023-07-17 | 153 | 0 |
| K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level | Cardinalhealth | 2023-07-03 | 124 | 0 |
| K230617 | Surgical Face Mask (L 175*95mm) | Henan Chaoya Medical Equipment Co., Ltd. | 2023-06-01 | 87 | 0 |
| K222545 | Disposable Medical Mask | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-05-19 | 270 | 0 |
| K223823 | Disposable Surgical Face Mask | Efofex, Inc. | 2023-03-27 | 96 | 0 |
| K223236 | Medline Surgical Face Mask and Medline Procedural Face Mask | Medline Industries, LP | 2023-03-24 | 156 | 0 |
| K221352 | Surgical Face Mask | Wuhan Huashida Protective Products Co., Ltd. | 2023-03-13 | 307 | 0 |
| K221209 | PRECISION ECO Compostable / Plant Based Procedural Mask with | Padm Medical, Inc. | 2023-03-08 | 316 | 0 |
| K230383 | Savvy Surgical Mask - Level 3 | Alg Health, LLC | 2023-03-06 | 21 | 0 |
| K223232 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2023-03-06 | 138 | 0 |
| K230093 | Disposable 4 Layers Surgical Face Mask | Social Medical Supply, LLC | 2023-03-02 | 49 | 0 |
| K223686 | Medical Protective Masks | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2023-02-07 | 60 | 0 |
| K221682 | Ideal Med Pro 3-Ply Disposable Face Mask | Jsn Holdings, LLC | 2023-01-13 | 217 | 0 |
| K203380 | Disposable Surgical Face Mask | Shandong Pop Jeans Intelligent Manufacturing Co., Ltd. | 2023-01-06 | 780 | 0 |
| K222483 | Surgical Face Mask | Hubei Woozon Healthcare Co., Ltd. | 2023-01-04 | 140 | 0 |
| K222809 | Medical Disposable Face Masks | Anqing Mayfield Medical Limited | 2023-01-03 | 109 | 0 |
| K213601 | Surgical Mask | Wuhan Zonsen Medical Products Co., Ltd. | 2022-12-16 | 396 | 0 |
| K220520 | PM Excellence SEQUR 100 Surgical Face Mask | Pm Excellence, LLC | 2022-12-15 | 295 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda