510(k) · Cleared
ClearedWellmien Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellmien (Suzhou) Import & Export Trading Co., Ltd. · FXX Mask, Surgical
Cleared on Aug 9, 2010 as substantially equivalent to K060776 (Hong YA Non-Woven Products Co., Ltd., 2006) after a 119-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Aug 9, 2010
- Review
- 119 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970835 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 2 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 1 generation backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- This deviceK101000 Wellmien Surgical MaskWellmien (Suzhou) Import & Export Trading Co., Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK123787 Greencross Surgical MaskJingzhou Haixin Green Cross Medical Products Co.,L · 2013
- Descendant · 2 generations on · 1 of its ownK141085 WestTec Procedure Facemask;WestTec Surgical FacemaskWesttec, LLC · 2015
- Descendant · cites it directly · 0 of its ownK220520 PM Excellence SEQUR 100 Surgical Face MaskPm Excellence, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK210513 UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask…Universal Incorporation · 2021
Most influential descendants
Showing 4 of 4 · See all- K123787Greencross Surgical MaskJingzhou Haixin Green Cross Medical Products Co.,L · 2013 · cites it directly2descendants
- K141085WestTec Procedure Facemask;WestTec Surgical FacemaskWesttec, LLC · 2015 · 2 generations on1descendant
- K220520PM Excellence SEQUR 100 Surgical Face MaskPm Excellence, LLC · 2022 · cites it directly0descendants
- K210513UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2Universal Incorporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −2 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −1 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | Westtec, LLC | 2015 | — |
| +1 | K220520 | PM Excellence SEQUR 100 Surgical Face Mask | Pm Excellence, LLC | 2022 | — |
| +3 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K060776 | Surgical Face MaskSummary page 1…Class: Class 2 Regulation Number: 21 CFR 807.4040 Product Code: FXX Classification Name: Mask, Surgical 3. Predicate Device Information: K060776: Surgical Face Mask (Yellow, White, Green, Pink) by Hong Ya Non- Woven Products Co., Ltd 4. Device description:… | 2006 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123787 (Jingzhou Haixin Green Cross Medical Products Co.,L, 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K060776.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Wellmien Surgical Masks (for single use only) are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K101000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101000: Wellmien Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101000
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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