510(k) · Cleared
ClearedDisposable Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lyncmed Medical Technology (Beijing) Co., Ltd. · FXX Mask, Surgical
Cleared on Oct 25, 2022 as substantially equivalent to K202029 (Beijing Biosis Healing Biolog Ical Technology Co., Ltd., 2020) after a 428-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Oct 25, 2022
- Review
- 428 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K970835 (1997). No later device cites it as a predicate yet.
- Root · 7 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 6 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 5 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 4 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 3 generations backK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
- 2 generations backK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
- 1 generation backK202029 Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020
- This deviceK212649 Disposable Surgical Face MaskLyncmed Medical Technology (Beijing) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −6 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −5 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −4 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −3 | K122717 | Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask | Tiger Medical Products, Ltd. | 2012 | — |
| −2 | K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | V&Q Manufacturing Corporation | 2018 | — |
| −1 | K202029 | Medical Surgical Mask | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020 | — |
| 0 (this device) | K212649 | Disposable Surgical Face Mask | Lyncmed Medical Technology (Beijing) Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K202029 | Medical Surgical MaskSummary page 5…9.5cm and 16.5×8.5cm. The device is single use and provided sterile. 5. Identification of Predicate Device 510(k) Number: K202029 Product Name: Medical Surgical Mask 6. Comparison of Technology with Predicate Device… | 2020 |
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 25 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K202029.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212649: Disposable Surgical Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212649
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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