510(k) · Cleared
ClearedSURGICAL FACE MASK (Ear Loops and Tie-on)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bh Medical Products Co., Ltd. · FXX Mask, Surgical
Cleared on Jun 22, 2015 as substantially equivalent to K131879 (Kimberly-Clark Corp., 2013) after a 630-day review. Its family tree reaches back 6 generations to 1987. 170 later devices descend from it.
- Decided
- Jun 22, 2015
- Review
- 630 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K874608 (1987). 8 ancestors in all, the oldest K801036 (1980). 170 later devices descend from it, 9 citing it directly.
- Root · 6 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 5 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 4 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 3 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 2 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 1 generation backK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- This deviceK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- Descendant · cites it directly · 158 of its ownK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- Descendant · 2 generations on · 50 of its ownK182515 Surgical Face MaskWuhan Dymex Healthcare Co., Ltd. · 2019
- Descendant · 2 generations on · 29 of its ownK182514 Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019
- Descendant · 2 generations on · 16 of its ownK200923 Single-use Surgical MaskByd Precision Manufacturer Co., Ltd. · 2020
- Descendant · 3 generations on · 13 of its ownK203426 Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021
Showing 5 of 170 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 170 · See all- K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016 · cites it directly158descendants
- K182515Surgical Face MaskWuhan Dymex Healthcare Co., Ltd. · 2019 · 2 generations on50descendants
- K182514Surgical Face MaskXiantao Zhibo Non-Woven Products Co., Ltd. · 2019 · 2 generations on29descendants
- K200923Single-use Surgical MaskByd Precision Manufacturer Co., Ltd. · 2020 · 2 generations on16descendants
- K203426Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. · 2021 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −5 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −4 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −3 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −2 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −1 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| 0 (this device) | 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 | — |
| +2 | K182515 | Surgical Face Mask | Wuhan Dymex Healthcare Co., Ltd. | 2019 | — |
| +2 | K182514 | Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2019 | — |
| +2 | K200923 | Single-use Surgical Mask | Byd Precision Manufacturer Co., Ltd. | 2020 | — |
| +3 | K203426 | Surgical Face Mask (non-sterile) | Nantong Taiweishi 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 10 | 0 |
| 2021 | 105 | 0 |
| 2022 | 40 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K131879 | KC 300 Surgical Mask Cleared while this submission was under review Summary page 4…Device Class: II Classification Name: Mask, Surgical Regulation Number: 21 CFR 878.4040 Product Code: FXX Review Panel: General & Plastic Surgery Predicate Device: • K131879 KIMBERLY-CLARK CORP KIMBERLY-CLARK, KC300 Mask 1… | 2013 |
What descends from it? (170)
See all 1709 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153496 | Disposable Surgical Face Mask | 2016 | 158 |
| K202761 | Medical Surgical Mask (Non-sterile) | 2021 | 2 |
| K202899 | Procedure Mask, Surgical Mask | 2021 | 1 |
| K212926 | AllureTM Surgical Mask | 2022 | 0 |
| K211696 | Disposable Surgical Face Mask | 2021 | 0 |
| K210698 | ECOMA Level 2 Disposable Surgical Mask with Ear Loops | 2021 | 0 |
| K210023 | Surgical Face Mask | 2021 | 0 |
| K202548 | Surgical Face Mask | 2021 | 0 |
| K202710 | Disposable Medical Face Mask | 2021 | 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 28 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K153496 (Xiantao Rayxin Medical Products Co., Ltd., 2016) has gone furthest, with 158 descendants of its own.
- 2 other devices also cite its predicate K131879.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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 is a single use, disposable device(s), provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133070: SURGICAL FACE MASK (Ear Loops and Tie-on).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133070
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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