510(k) · Cleared
ClearedMedical surgical mask (Black mask, Level 1 and Level 3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Kingfa Sci. & Tech.Co., Ltd. · FXX Mask, Surgical
Cleared on Apr 5, 2022 as substantially equivalent to K201622 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2020) and 1 other predicate after a 161-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Apr 5, 2022
- Review
- 161 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K874608 (1987). 20 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 7 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 6 generations backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- 5 generations backK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
- 4 generations backK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
- 3 generations backK092580 Tidi FacemaskTidi Products,Llc · 2010
- 2 generations backK093179 Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010
- 1 generation backK202139 Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020
- This deviceK213450 Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −7 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −6 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| −5 | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or… | Valumax Intl., Inc. | 2004 | — |
| −4 | K051291 | Non-Sterile Surgical Mask | A.R. Medicom, Inc. | 2005 | 5 |
| −3 | K092580 | Tidi Facemask | Tidi Products,Llc | 2010 | — |
| −2 | K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) | H&H Research Company | 2010 | — |
| −1 | K202139 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020 | — |
| 0 (this device) | K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K201622 | Medical surgical maskSummary page 4…tion Sponsor: Guangdong KINGFA Sci.&Tech.Co.,Ltd. Trade/Device Name: Medical surgical mask Classification Name: Mask, Surgical Common Name: Mask, Surgical 510(K) Number: K201622 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 1… | 2020 |
| * | K202139 | Medical surgical maskSummary page 5…tion Sponsor: Guangdong KINGFA Sci.&Tech.Co.,Ltd. Trade/Device Name: Medical surgical mask Classification Name: Mask, Surgical Common Name: Mask, Surgical 510(K) Number: K202139 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II 4. Device Description The med… | 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 35 years and passes through 8 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 20 ancestors have a recall of any class.
- 1 other device also cites its predicate K201622.
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?
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213450: Medical surgical mask (Black mask, Level 1 and Level 3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213450
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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