510(k) Report

510(k) · Cleared

Cleared

Fluidshield* Surgical Mask with Expanded Chamber

K143287510(k) AbbreviatedCleared Mar 24, 2015127-day reviewClass II21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Halyard Health, Inc. · FXX Mask, Surgical

Cleared on Mar 24, 2015 as substantially equivalent to K111402 (Kimberly-Clark, 2011) after a 127-day review. Its family tree reaches back 5 generations to 1987. 10 later devices descend from it.

Decided
Mar 24, 2015
Review
127 days
Class
Class II
Product code
FXX
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K874608 (1987). 7 ancestors in all, the oldest K801036 (1980). 10 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1980: 1 other ancestor1991: 1 other ancestor2021: 6 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant clearedK874608 · Tecnol Fluid Shield Surgical Mask · Tecnol New Jersey Wound Care, Inc. · 1987K955556 · Fluid Resistant Mask · American Threshold Healthcare · 1996K082258 · Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor · Crosstex International · 2008×2: 2 generations cleared close together, K110455 (2011), K111402 (2011) 19801990200020102020
Other ancestors, by generationDescendants, by generation 4 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K111402 · KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model · Kimberly-Clark · 2011K110455 · Kimberly-Clark Low Barrier, Astm 2100 Face Masks · Kimberly-Clark Corp. · 2011K082258 · Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor · Crosstex International · 2008K955556 · Fluid Resistant Mask · American Threshold Healthcare · 1996K874608 · Tecnol Fluid Shield Surgical Mask · Tecnol New Jersey Wound Care, Inc. · 1987−50
  1. Root · 5 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
  2. 4 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
  3. 3 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
  4. 2 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
  5. 1 generation backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
  6. This deviceK143287 Fluidshield* Surgical Mask with Expanded ChamberHalyard Health, Inc. · 2015
  7. Descendant · cites it directly · 4 of its ownK201537 Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd. · 2020
  8. Descendant · cites it directly · 2 of its ownK180874 3M High Performance Surgical Mask, 3M High Performance Surgical Mask…3M Healthcare · 2018
  9. Descendant · 2 generations on · 1 of its ownK212205 Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd. · 2021
  10. Descendant · 2 generations on · 1 of its ownK210445 Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2021
  11. Descendant · 2 generations on · 1 of its ownK202107 Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2018: 12020: 12021: 62023: 12024: 1
2018high 6 (2021) · low 0 (2019)2026

Most influential descendants

Showing 5 of 10 · See all
  • K201537Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd. · 2020 · cites it directly4descendants
  • K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare · 2018 · cites it directly2descendants
  • K212205Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd. · 2021 · 2 generations on1descendant
  • K210445Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd. · 2021 · 2 generations on1descendant
  • K202107Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K874608Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc.1987—
−4K955556Fluid Resistant MaskAmerican Threshold Healthcare1996—
−3K082258Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face…Crosstex International2008—
−2K110455Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp.2011—
−1K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield…Kimberly-Clark2011—
0 (this device)K143287Fluidshield* Surgical Mask with Expanded ChamberHalyard Health, Inc.2015—
+1K201537Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd.2020—
+1K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face…3M Healthcare2018—
+2K212205Medical Protective MasksQinhuangdao Taizhi Medical Technology Co., Ltd.2021—
+2K210445Nordiwell Surprotect Face MaskChangzhou Combat Protective Equipment Co., Ltd.2021—
+2K202107Medical Protective MaskGuangdong Kingfa Sci. & Tech.Co., Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202010
202160
202310
202410
FIG. 1 — Lineage of K143287, 1987–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…
Summary page 5
…Chamber, the Device subject of this submission, is substantially equivalent to the Kimberly-Clark Level 2 face masks originally cleared in K111402. Component Predicate Device KC200 & 300 Surgical FLUIDSHIELD* Surgical Mask with Mask (K111402…
Kimberly-Clark2011—

Also cleared against K111402: 8 other devices →

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201537Protective Face Mask for Medical UseShandong Shengquan New Material Co., Ltd.20204
K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield3M Healthcare20182
K232894HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining…Owens & Minor (O&M) Halyard, Inc.20240
K202358Protective Face Mask for Medical UseHunan Heng Chang Pharmaceutical Co., Ltd.20210

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 3.4 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K201537 (Shandong Shengquan New Material Co., Ltd., 2020) has gone furthest, with 4 descendants of its own.
  • 8 other devices also cite its predicate K111402.

How does its category compare?

All FXX devices

FXX 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

2007: 22008: 22009: 12010: 72011: 62012: 12013: 32014: 12015: 52016: 52017: 12018: 32019: 42020: 272021: 2182022: 912023: 222024: 152025: 62026 (partial year): 5
2007high 218 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FXX

123in 2025

2010: 144 days median2011: 137 days median2013: 219 days median2015: 298 days median2016: 268 days median2018: 119 days median2019: 124 days median2020: 113 days median2021: 162 days median2022: 113 days median2023: 139 days median2024: 263 days median2025: 123 days median2026 (partial year): 142 days median
2007high 298 (2015) · low 113 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FXX

2in 2024

2019: 22023: 12024: 2
2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FXX

11in 2025

2007: 112008: 102009: 32010: 92011: 82012: 222013: 92014: 52015: 142016: 162017: 452018: 212019: 232020: 602021: 672022: 212023: 212024: 212025: 11
2007high 67 (2021) · low 3 (2009)2025

MAUDE reports naming product code FXX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—011
20082—010
20091—03
2010714409
2011613708
20121—022
2013321909
20141—05
20155298014
20165268016
20171—045
20183119021
20194124223
202027113060
2021218162067
202291113021
202322139121
202415263221
20256123011
202651420—

What is it indicated for?

The Expanded Chamber Surgical Face Mask 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 to blood and body fluids. This is a single use, disposable device(s),

provided non-sterile.

39123 Expanded Chamber Surgical Face Masks w/o Visor

39124 Expanded Chamber Surgical Face Mask with Visor

Indications for use as stated in the FDA summary.

Also cleared against K111402

8 other devices cite the same predicate.

  • K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD*…O&M Halyard, Inc. · 2026
  • K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical…Owens & Minor (O&M) Halyard, Inc. · 2025
  • K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor…Owens & Minor (O&M) Halyard, Inc. · 2024
  • K220377Procedure MaskLittle Rapids Corporation · 2022
  • K210101American-Made Surgical MaskArmbrust, Inc. · 2022
  • K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. · 2016

More from Halyard Health, Inc.

7 FDA decisions under this applicant name. See the company

  • K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc. · 2018
  • K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc. · 2017
  • K163461Coolief* Cooled RF ProbeHalyard Health, Inc. · 2017
  • K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016
  • K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016

Recent decisions in FXX

The FXX category page

  • K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD*…O&M Halyard, Inc. · 2026
  • K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd. · 2026
  • K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc. · 2026
  • K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd. · 2026
  • K252650Disposable Medical Face MaskMakrite Industries, Inc. · 2026

https://510kreport.com/device/K143287 · printed Nov 4, 2026

Cite this page

510(k) Report. “K143287: Fluidshield* Surgical Mask with Expanded Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143287

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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