510(k) · Cleared
ClearedWinner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with Shield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winner Industries (Shenzhen) Co., Ltd. · FXX Mask, Surgical
Cleared on Jun 10, 2003 as substantially equivalent to K012602 (Crosstex Intl., 2002) and 1 other predicate after a 214-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jun 10, 2003
- Review
- 214 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K874608 (1987). 6 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 3 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 2 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 1 generation backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- This deviceK023755 Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop…Winner Industries (Shenzhen) Co., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −2 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −1 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| 0 (this device) | K023755 | Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask… | Winner Industries (Shenzhen) Co., Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FXX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FXX device
- #1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 4 other devices also cite its predicate K012602.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
Winner Medical facemask / shield are intended to be used by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate matter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023755: Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023755
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026