510(k) · Cleared
ClearedWestTec Procedure Facemask;WestTec Surgical Facemask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Westtec, LLC · FXX Mask, Surgical
Cleared on Mar 27, 2015 as substantially equivalent to K123787 (Jingzhou Haixin Green Cross Medical Products Co.,L, 2013) after a 333-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Mar 27, 2015
- Review
- 333 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970835 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 4 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 3 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 2 generations backK101000 Wellmien Surgical MaskWellmien (Suzhou) Import & Export Trading Co., Ltd. · 2010
- 1 generation backK123787 Greencross Surgical MaskJingzhou Haixin Green Cross Medical Products Co.,L · 2013
- This deviceK141085 WestTec Procedure Facemask;WestTec Surgical FacemaskWesttec, LLC · 2015
- Descendant · cites it directly · 0 of its ownK210513 UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask…Universal Incorporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K210513UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2Universal Incorporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −4 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −3 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −2 | K101000 | Wellmien Surgical Mask | Wellmien (Suzhou) Import & Export Trading Co., Ltd. | 2010 | — |
| −1 | K123787 | Greencross Surgical Mask | Jingzhou Haixin Green Cross Medical Products Co.,L | 2013 | — |
| 0 (this device) | K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | Westtec, LLC | 2015 | — |
| +1 | K210513 | UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM… | Universal Incorporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123787 | Greencross Surgical MaskSummary page 4…Surgical facemasks, the subject of this submission, are substantially equivalent to the Jingzhou Haixin Green Cross Medical Products Co., Ltd Surgical Mask (K123787). Device Description: The WestTec Procedure and Surgical facemasks are identical with the exception that the Surgi… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210513 | UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 | 2021 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210513 (Universal Incorporation, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
WestTec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141085: WestTec Procedure Facemask;WestTec Surgical Facemask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141085
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