510(k) · Cleared
ClearedSurgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiantao Zhibo Non-Woven Products Co., Ltd. · FXX Mask, Surgical
Cleared on Jan 24, 2019 as substantially equivalent to K153496 (Xiantao Rayxin Medical Products Co., Ltd., 2016) after a 134-day review. Its family tree reaches back 8 generations to 1987. 29 later devices descend from it.
- Decided
- Jan 24, 2019
- Review
- 134 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K874608 (1987). 10 ancestors in all, the oldest K801036 (1980). 29 later devices descend from it, 9 citing it directly.
- 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 backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 5 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 4 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 3 generations backK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- 2 generations backK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- 1 generation backK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- This deviceK182514 Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019
- Descendant · cites it directly · 13 of its ownK203426 Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK211631 Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK202511 Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK221272 Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK212097 Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd. · 2021
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K203426Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021 · cites it directly13descendants
- K211631Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd. · 2021 · 2 generations on4descendants
- K202511Disposable Medical Surgical MaskImprove Medical (Hunan) Co., Ltd. · 2021 · cites it directly4descendants
- K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd. · 2022 · 3 generations on2descendants
- K212097Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd. · 2021 · 2 generations on2descendants
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 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −5 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −4 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −3 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| −2 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | Bh Medical Products Co., Ltd. | 2015 | — |
| −1 | K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2016 | — |
| 0 (this device) | K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019 | — |
| +1 | K203426 | Surgical Face Mask (non-sterile) | Nantong Taiweishi Medical Technology Co., Ltd. | 2021 | — |
| +2 | K211631 | Surgical Face Mask | Macheng Thimble Technology Investment Co., Ltd. | 2021 | — |
| +1 | K202511 | Disposable Medical Surgical Mask | Improve Medical (Hunan) Co., Ltd. | 2021 | — |
| +3 | K221272 | Medical Face Mask | Shandong Xingyu Gloves Co., Ltd. | 2022 | — |
| +2 | K212097 | Disposable medical surgical mask | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 18 | 0 |
| 2022 | 8 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K153496 | Disposable Surgical Face MaskSummary page 4…tion Classification Name: Surgical Face Mask Classification: Class II. Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel C. Predicate device: K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., Ltd. D. Indications for Use: The Disposable Surgical Face Mas… | 2016 |
What descends from it? (29)
See all 299 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203426 | Surgical Face Mask (non-sterile) | 2021 | 13 |
| K202511 | Disposable Medical Surgical Mask | 2021 | 4 |
| K210063 | Freudenberg Surgical Mask | 2021 | 2 |
| K210007 | Face Mask | 2021 | 1 |
| K212059 | Surgical Face Mask | 2021 | 0 |
| K212235 | Surgical Face Mask | 2021 | 0 |
| K210042 | Disposable Surgical Mask | 2021 | 0 |
| K210856 | Purism Disposable Surgical Mask | 2021 | 0 |
| K201893 | Disposable Surgical Mask | 2020 | 0 |
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 32 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K203426 (Nantong Taiweishi Medical Technology Co., Ltd., 2021) has gone furthest, with 13 descendants of its own.
- 39 other devices also cite its predicate K153496.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182514: 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/K182514
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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