510(k) · Cleared

Cleared

Fluid Resistant Mask

K955556510(k) TraditionalCleared Apr 25, 1996142-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

American Threshold Healthcare · FXX Mask, Surgical

Cleared on Apr 25, 1996 as substantially equivalent to K874608 (Tecnol New Jersey Wound Care, Inc., 1987) and 1 other predicate after a 142-day review. Its family tree reaches back 1 generation to 1987. 329 later devices descend from it.

Decided: Apr 25, 1996
Review: 142 days
Class: Class II
Product code: FXX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K874608 (1987). 2 ancestors in all. 329 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
This deviceK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
Descendant · cites it directly · 299 of its ownK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
Descendant · 2 generations on · 289 of its ownK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
Descendant · 3 generations on · 262 of its ownK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
Descendant · 3 generations on · 185 of its ownK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
Descendant · 4 generations on · 170 of its ownK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015

Showing 5 of 329 descendants. See all descendants

Descendants cleared per year

2002high 165 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 329 · See all

K082258Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with…Crosstex International · 2008 · cites it directly299descendants
K110455Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011 · 2 generations on289descendants
K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Kimberly-Clark · 2011 · 3 generations on262descendants
K131879KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · 3 generations on185descendants
K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015 · 4 generations on170descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K874608	Tecnol Fluid Shield Surgical Mask	Tecnol New Jersey Wound Care, Inc.	1987	—
0 (this device)	K955556	Fluid Resistant Mask	American Threshold Healthcare	1996	—
+1	K082258	Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face…	Crosstex International	2008	—
+2	K110455	Kimberly-Clark Low Barrier, Astm 2100 Face Masks	Kimberly-Clark Corp.	2011	—
+3	K111402	KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield…	Kimberly-Clark	2011	—
+3	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2005	2	0
2006	1	0
2007	1	0
2008	1	0
2010	4	0
2011	5	0
2012	1	0
2013	1	0
2014	1	0
2015	4	0
2016	4	0
2018	1	0
2019	5	0
2020	17	0
2021	165	0
2022	75	0
2023	17	0
2024	13	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K955556, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K874608	Tecnol Fluid Shield Surgical Mask Summary page 1 …riginal - December 4, 1995 Device Name: Fluid Resistant Mask Classification Name: MASK, SURGICAL Predicate Device(s): 1. Tecnol Fluid Resistant Surgical Mask, 510 (k) #K874608, dated December 2, 1987. 2. 3M Fluid Resistant Mask, 510 (k) #K910110, dated March 20, 1991 Device Description: The Fluid Resi…	Tecnol New Jersey Wound Care, Inc.	1987	—
*	K910110	Triple Layer Fluid-Resistant Molded Face Mask Summary page 1 …ation Name: MASK, SURGICAL Predicate Device(s): 1. Tecnol Fluid Resistant Surgical Mask, 510 (k) #K874608, dated December 2, 1987. 2. 3M Fluid Resistant Mask, 510 (k) #K910110, dated March 20, 1991 Device Description: The Fluid Resistant Masks are constructed of a light weight spunbonded polyolefin or…	3M Company	1991	—
†	K801036	Surgical Mask	American Threshold Industries, Inc.	1980	1

Also cleared against K874608: 1 other device →

What descends from it? (329)

See all 329

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

Number	Device	Applicant	Decided	Descendants
K082258	Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with…	Crosstex International	2008	299
K012602	Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face…	Crosstex Intl.	2002	28

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?

None of the 2 ancestors has a recall.
Of its descendants, K082258 (Crosstex International, 2008) has gone furthest, with 299 descendants of its own.
1 other device also cites its predicate K874608.

How does its category compare?

All FXX devices

FXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXX

6in 2025

2007high 218 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FXX

123in 2025

2007high 298 (2015) · low 113 (2020)2026

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

Recalls per year · FXX

2in 2024

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

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

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?

This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K955556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955556: Fluid Resistant Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955556

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