510(k) · Cleared

Cleared

Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without Visors, Ties and Earloops

K040333510(k) TraditionalCleared Jun 7, 2004117-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

Valumax Intl., Inc. · FXX Mask, Surgical

Cleared on Jun 7, 2004 as substantially equivalent to K012602 (Crosstex Intl., 2002) after a 117-day review. Its family tree reaches back 3 generations to 1987. 21 later devices descend from it.

Decided: Jun 7, 2004
Review: 117 days
Class: Class II
Product code: FXX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K874608 (1987). 5 ancestors in all, the oldest K801036 (1980). 21 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
2 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
1 generation backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
This deviceK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
Descendant · cites it directly · 20 of its ownK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
Descendant · 2 generations on · 9 of its ownK092580 Tidi FacemaskTidi Products,Llc · 2010
Descendant · cites it directly · 6 of its ownK061864 Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540…Dukal Corp. · 2006
Descendant · 2 generations on · 4 of its ownK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
Descendant · 3 generations on · 3 of its ownK201137 Asept Surgical Face MaskPfm Medical, Inc. · 2020

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2005high 7 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 21 · See all

K051291Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · cites it directly20descendants
K092580Tidi FacemaskTidi Products,Llc · 2010 · 2 generations on9descendants
K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp. · 2006 · cites it directly6descendants
K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011 · 2 generations on4descendants
K201137Asept Surgical Face MaskPfm Medical, Inc. · 2020 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K874608	Tecnol Fluid Shield Surgical Mask	Tecnol New Jersey Wound Care, Inc.	1987	—
−2	K955556	Fluid Resistant Mask	American Threshold Healthcare	1996	—
−1	K012602	Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face…	Crosstex Intl.	2002	—
0 (this device)	K040333	Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or…	Valumax Intl., Inc.	2004	—
+1	K051291	Non-Sterile Surgical Mask	A.R. Medicom, Inc.	2005	5
+2	K092580	Tidi Facemask	Tidi Products,Llc	2010	—
+1	K061864	Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with…	Dukal Corp.	2006	—
+2	K111559	Surgical Masks	Shanghai Neo-Medical Import & Export Co., Ltd.	2011	—
+3	K201137	Asept Surgical Face Mask	Pfm Medical, Inc.	2020	—

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
2005	1	0
2006	1	0
2007	1	0
2010	3	0
2011	2	0
2015	1	0
2016	1	0
2020	2	0
2021	7	0
2022	2	0

FIG. 1 — Lineage of K040333, 1987–2022Source: 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? (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	Applicant	Decided	Recalls
*	K012602	Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… Summary page 2 …2-7937188 Fax: 86-532-7937288 C. 510(K) SUMMARY - Continued 5. Classification Name: Mask, Surgical 6. Predicate Device Information: K012602 - Crosstex Surgical Masks 7. Device Description: ValuMaxR Surgical Masks are pleated 3-ply masks. Inner and outer layers ar…	Crosstex Intl.	2002	—

Also cleared against K012602: 4 other devices →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K051291	Non-Sterile Surgical Mask	A.R. Medicom, Inc.	2005	20
K061864	Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560	Dukal Corp.	2006	6

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 17 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K051291 (A.R. Medicom, Inc., 2005) has gone furthest, with 20 descendants of its own.
4 other devices also cite its predicate K012602.

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?

ValuMaxE Surgical Masks is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040333 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040333: Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without Visors, Ties and Earloops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040333

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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