510(k) · Cleared
ClearedKC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark · FXX Mask, Surgical
Cleared on Oct 20, 2011 as substantially equivalent to K110455 (Kimberly-Clark Corp., 2011) after a 154-day review. Its family tree reaches back 4 generations to 1987. 262 later devices descend from it.
- Decided
- Oct 20, 2011
- Review
- 154 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K874608 (1987). 6 ancestors in all, the oldest K801036 (1980). 262 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 3 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 2 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 1 generation backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- This deviceK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- Descendant · cites it directly · 185 of its ownK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- Descendant · 2 generations on · 170 of its ownK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- Descendant · 3 generations on · 158 of its ownK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
- Descendant · cites it directly · 60 of its ownK160269 Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. · 2016
- Descendant · 4 generations on · 50 of its ownK182515 Surgical Face MaskWuhan Dymex Healthcare Co., Ltd. · 2019
Showing 5 of 262 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 262 · See all- K131879KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · cites it directly185descendants
- K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015 · 2 generations on170descendants
- K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016 · 3 generations on158descendants
- K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. · 2016 · cites it directly60descendants
- K182515Surgical Face MaskWuhan Dymex Healthcare Co., Ltd. · 2019 · 4 generations on50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −3 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −2 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −1 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| 0 (this device) | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| +1 | 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 | — |
| +3 | K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2016 | — |
| +1 | K160269 | Surgical Face Masks (Ear loops and Tie-on) | San-M Package Co., Ltd. | 2016 | — |
| +4 | K182515 | Surgical Face Mask | Wuhan Dymex Healthcare Co., Ltd. | 2019 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 14 | 0 |
| 2021 | 146 | 0 |
| 2022 | 65 | 0 |
| 2023 | 13 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face MasksSummary page 1…Mask, surgical (21 CFR 678.4040) Classification Names: Predicate Devices The Kimberly-Clark KC100 face mask(s) subject of K1 10455. The Kimberly-Clark Face Mask(s) is a four layer mask,… | 2011 |
What descends from it? (262)
See all 2629 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131879 | KC 300 Surgical Mask | 2013 | 185 |
| K160269 | Surgical Face Masks (Ear loops and Tie-on) | 2016 | 60 |
| K143287 | Fluidshield* Surgical Mask with Expanded Chamber | 2015 | 10 |
| K140155 | Secure-Gard Surgical and Procedure Face Mask | 2014 | 4 |
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*… | 2026 | 0 |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)… | 2025 | 0 |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask… | 2024 | 0 |
| K220377 | Procedure Mask | 2022 | 0 |
| K210101 | American-Made Surgical Mask | 2022 | 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 24 years and passes through 5 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K131879 (Kimberly-Clark Corp., 2013) has gone furthest, with 185 descendants of its own.
- 18 other devices also cite its predicate K110455.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Kimberly-Clark, K0200 and KC300 Face Mask(s) is 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 of the wearer to blood and body fluids. The Kimberly-Clark, KC200 and KC300 face mask(s) is a single use, disposable device(s), provided non-sterile. KC200…
Read the full statement (119 words)
The Kimberly-Clark, K0200 and KC300 Face Mask(s) is 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 of
the wearer to blood and body fluids. The Kimberly-Clark, KC200 and KC300
face mask(s) is a single use, disposable device(s), provided non-sterile.
KC200 Procedure Mask
KC200 Procedure Mask, fog free with visor
KC200 Surgical Mask, fog free
KC200 Surgical Mask, fog free with visor
KC300 Procedure Mask, Fluidshieldt , fog free
KC300 Procedure Mask, Fluidshieldt , fog free with visor
KC300 Surgical Mask, Fluidshield, fog free
KC300 Surgical Mask, Fluidshield*, fog free with visor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111402
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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