510(k) · Cleared
ClearedGreencross Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jingzhou Haixin Green Cross Medical Products Co.,L · FXX Mask, Surgical
Cleared on Jul 17, 2013 as substantially equivalent to K101000 (Wellmien (Suzhou) Import & Export Trading Co., Ltd., 2010) after a 219-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Jul 17, 2013
- Review
- 219 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970835 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 3 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 2 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 1 generation backK101000 Wellmien Surgical MaskWellmien (Suzhou) Import & Export Trading Co., Ltd. · 2010
- This deviceK123787 Greencross Surgical MaskJingzhou Haixin Green Cross Medical Products Co.,L · 2013
- Descendant · cites it directly · 1 of its ownK141085 WestTec Procedure Facemask;WestTec Surgical FacemaskWesttec, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK210513 UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask…Universal Incorporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −3 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −2 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −1 | K101000 | Wellmien Surgical Mask | Wellmien (Suzhou) Import & Export Trading Co., Ltd. | 2010 | — |
| 0 (this device) | K123787 | Greencross Surgical Mask | Jingzhou Haixin Green Cross Medical Products Co.,L | 2013 | — |
| +1 | K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | Westtec, LLC | 2015 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K101000 | Wellmien Surgical MaskSummary page 1…sification: Class 11 Regulation Number: 878.4040 Product Code: FXX Classification Name: Mask, Surgical 3. Predicate Device Information: K101000: Surgical Mask (For Single Use Only) by Wellmien (Suzhoti) Imp. & Exp. Trading Co., Ltd 4. Device description:… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141085 | WestTec Procedure Facemask;WestTec Surgical Facemask | 2015 | 1 |
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 4.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K141085 (Westtec, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K101000.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 GreenCross Surgical Masks 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 summary.
https://510kreport.com/device/K123787 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123787: Greencross Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123787
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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