510(k) · Cleared

Recalled · 2003

Surgical Mask

K801036510(k) TraditionalCleared Jun 4, 198033-day reviewClass II21 CFR 878.4040Recalls 1

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

American Threshold Industries, Inc. · FXX Mask, Surgical

Cleared on Jun 4, 1980 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 329 later devices descend from it. It has been recalled once.

Decided: Jun 4, 1980
Review: 33 days
Class: Class II
Product code: FXX
Recalls: 1
Predicates: 0

329 later devices descend from it, 2 citing it directly.

This deviceK801036 Surgical MaskAmerican Threshold Industries, Inc. · 1980
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
0 (this device)	K801036	Surgical Mask	American Threshold Industries, Inc.	1980	—
+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	—

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 K801036, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 3, 2003	Not classified	Z-0944-03	Other	The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K082258 (Crosstex International, 2008) has gone furthest, with 299 descendants of its own.

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	—

https://510kreport.com/device/K801036 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801036: Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801036

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026