510(k) · Cleared
ClearedDisposable medical surgical mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hebei Titans Hongsen Medical Technology Co., Ltd. · FXX Mask, Surgical
Cleared on Aug 18, 2021 as substantially equivalent to K202511 (Improve Medical (Hunan) Co., Ltd., 2021) after a 43-day review. Its family tree reaches back 10 generations to 1987. 2 later devices descend from it.
- Decided
- Aug 18, 2021
- Review
- 43 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K874608 (1987). 12 ancestors in all, the oldest K801036 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 6 generations between
- 3 generations backK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- 2 generations backK182514 Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019
- 1 generation backK202511 Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd. · 2021
- This deviceK212097 Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK221222 Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK222651 Surgical Face MaskXiantao Sanda Industrial Co., Ltd. · 2022
Show all 10 generations
- Root · 10 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 9 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 8 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 7 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 6 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 5 generations backK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- 4 generations backK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- 3 generations backK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- 2 generations backK182514 Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019
- 1 generation backK202511 Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd. · 2021
- This deviceK212097 Disposable medical surgical maskHebei Titans Hongsen Medical Technology 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 |
|---|---|---|---|---|---|
| −10 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −9 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −8 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −7 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −6 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −5 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| −4 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | Bh Medical Products Co., Ltd. | 2015 | — |
| −3 | K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2016 | — |
| −2 | K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019 | — |
| −1 | K202511 | Disposable Medical Surgical Mask | Improve Medical (Hunan) Co., Ltd. | 2021 | — |
| 0 (this device) | K212097 | Disposable medical surgical mask | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021 | — |
| +1 | K221222 | Surgical Face Mask (HNFM0304) | Shanghai Hua EN Industrial Co, Ltd. | 2022 | — |
| +2 | K222651 | Surgical Face Mask | Xiantao Sanda Industrial Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K202511 | Disposable Medical Surgical MaskSummary page 5…The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices. 5. Identification of Predicate Device(s) 510(k) number: K202511 Device Name: Disposable Medical Surgical Mask Manufacturer: Improve Medical (HuNan) Co., Ltd. 6. Technological Char… | 2021 |
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 |
|---|---|---|---|
| K221222 | Surgical Face Mask (HNFM0304) | 2022 | 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 34 years and passes through 10 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K221222 (Shanghai Hua EN Industrial Co, Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K202511.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212097: Disposable medical surgical mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212097
Report an extraction error
Are you the manufacturer?
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