510(k) · Cleared
ClearedMedical Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · FXX Mask, Surgical
Cleared on Dec 16, 2020 as substantially equivalent to K173062 (V&Q Manufacturing Corporation, 2018) after a 147-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 16, 2020
- Review
- 147 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970835 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 5 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 4 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 3 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 2 generations backK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
- 1 generation backK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
- This deviceK202029 Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK212649 Disposable Surgical Face MaskLyncmed Medical Technology (Beijing) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210518 Surgical Face MaskShandong Haidike Medical Products Co., Ltd. · 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 |
|---|---|---|---|---|---|
| −6 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −5 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −4 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −3 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −2 | K122717 | Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask | Tiger Medical Products, Ltd. | 2012 | — |
| −1 | K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | V&Q Manufacturing Corporation | 2018 | — |
| 0 (this device) | K202029 | Medical Surgical Mask | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020 | — |
| +1 | K212649 | Disposable Surgical Face Mask | Lyncmed Medical Technology (Beijing) Co., Ltd. | 2022 | — |
| +1 | K210518 | Surgical Face Mask | Shandong Haidike Medical Products Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))Summary page 5…mber: 21CFR 878.4040 Review Panel: General Hospital 4. Identification of Predicate Device Manufacturer: V&Q Manufacturing Corporation 510(k) Number: K173062 Product Name: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) 5. Indication for use: The med… | 2018 |
What descends from it? (2)
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 23 years and passes through 6 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K212649 (Lyncmed Medical Technology (Beijing) Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K173062.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 medical surgical 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/K202029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202029: Medical 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/K202029
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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