510(k) Report

510(k) · Cleared

Cleared

DemeMASK

K201479510(k) AbbreviatedCleared Jul 24, 202050-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

Demetech Corporation · FXX Mask, Surgical

Cleared on Jul 24, 2020 as substantially equivalent to K173062 (V&Q Manufacturing Corporation, 2018) after a 50-day review. Its family tree reaches back 6 generations to 1997. 17 later devices descend from it.

Decided
Jul 24, 2020
Review
50 days
Class
Class II
Product code
FXX
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K970835 (1997). 17 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2021: 12 descendants cleared2022: 3 descendants cleared2024: 1 descendant cleared2026: 1 descendant clearedK970835 · Face Mask, Surgical Mask, Non-Sterile · Tucker & Associates · 1997K022256 · Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green · Tucker & Associates · 2004×2: 2 generations cleared close together, K060776 (2006), K061716 (2006) K122717 · Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask · Tiger Medical Products, Ltd. · 2012K173062 · Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) · V&Q Manufacturing Corporation · 20181995200020052010201520202025
Descendants, by generation 1 generation forward: 13 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K173062 · Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) · V&Q Manufacturing Corporation · 2018K122717 · Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask · Tiger Medical Products, Ltd. · 2012K061716 · Prestige Ameritech Face Mask · Prestige Ameritech · 2006K060776 · Surgical Face Mask · Hong YA Non-Woven Products Co., Ltd. · 2006K022256 · Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green · Tucker & Associates · 2004K970835 · Face Mask, Surgical Mask, Non-Sterile · Tucker & Associates · 1997−50
  1. Root · 6 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
  2. 5 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
  3. 4 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
  4. 3 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
  5. 2 generations backK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
  6. 1 generation backK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
  7. This deviceK201479 DemeMASKDemetech Corporation · 2020
  8. Descendant · cites it directly · 4 of its ownK210030 Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd. · 2021
  9. Descendant · 2 generations on · 1 of its ownK220597 Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd. · 2022
  10. Descendant · 3 generations on · 0 of its ownK252830 Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd. · 2026
  11. Descendant · 2 generations on · 0 of its ownK231719 Medical Surgical MaskAzur Medical Company, Inc. · 2024
  12. Descendant · cites it directly · 0 of its ownK213920 Kangbeier Surgical Mask (Model: KBR-1001)Xinxiang Kangbeier Medical Technology Co., Ltd. · 2022

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2021: 122022: 32024: 12026: 1
2021high 12 (2021) · low 0 (2023)2026

Most influential descendants

Showing 5 of 17 · See all
  • K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd. · 2021 · cites it directly4descendants
  • K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd. · 2022 · 2 generations on1descendant
  • K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd. · 2026 · 3 generations on0descendants
  • K231719Medical Surgical MaskAzur Medical Company, Inc. · 2024 · 2 generations on0descendants
  • K213920Kangbeier Surgical Mask (Model: KBR-1001)Xinxiang Kangbeier Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K970835Face Mask, Surgical Mask, Non-SterileTucker & Associates1997—
−5K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates2004—
−4K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd.2006—
−3K061716Prestige Ameritech Face MaskPrestige Ameritech2006—
−2K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd.2012—
−1K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation2018—
0 (this device)K201479DemeMASKDemetech Corporation2020—
+1K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.2021—
+2K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.2022—
+3K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.2026—
+2K231719Medical Surgical MaskAzur Medical Company, Inc.2024—
+1K213920Kangbeier Surgical Mask (Model: KBR-1001)Xinxiang Kangbeier Medical Technology Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
2021120
202230
202410
202610
FIG. 1 — Lineage of K201479, 1997–2026Source: 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 K200847 Surgical Face Maskscore 32.2 · 1 generation · 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
*K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
Summary page 4
…878.4040 Review Panel: Surgical Apparel E. Predicate Device: 510(k) K173062 Trade Name: Non Woven Face Mask (Model: VQN0185W (earloop) Manufacturer:…
V&Q Manufacturing Corporation2018—

Also cleared against K173062: 7 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.20214
K213920Kangbeier Surgical Mask (Model: KBR-1001)Xinxiang Kangbeier Medical Technology Co., Ltd.20220
K212302BAYLAB 3-Ply Surgical Mask (BEACON I)Baylab USA, LLC20210
K213406Savvy Mask - Level 3 Surgical Face MaskTexas Medplast, LLC20210
K210813Medical Surgical MaskSichuan Pharmaceutical., Inc.20210
K210184Wilson Tech Disposable Medical Face MaskWilson Tech (International) Limited20210
K212451Surgical MaskRemade USA, LLC20210
K210391Single-use medical face maskZhuhai Herald Datanetics Limited.20210
K201844Surgical Face Mask, Surgical MaskLear Corporation20210
K202580Disposable Surgical MaskQingdao Likangyuan Medical Device 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 23 years and passes through 6 companies; a new generation was cleared every 5.1 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K210030 (Tianjin Aoshang Outdoor Equipment Co., Ltd., 2021) has gone furthest, with 4 descendants of its own.
  • 7 other devices also cite its predicate K173062.

How does its category compare?

All FXX devices

FXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Disposable Surgical Face Masks are 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 provided non-sterile.

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

Also cleared against K173062

7 other devices cite the same predicate.

  • K211487MAF GuardMaf Clothing Pvt Ltd Unit-3 · 2021
  • K203704Surgical face maskJuntech (Jiaxing)Healthcare Materials Co,.Ltd · 2021
  • K202628Disposable Medical Face MaskQinghai Zhong Dao Win-Win Medical Protective Equipment Co., · 2021
  • K202904Surgical Face MaskJiangxi Feilikang Medical Technology Co., Ltd. · 2021
  • K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2021
  • K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd. · 2021

More from Demetech Corporation

5 FDA decisions under this applicant name. See the company

  • K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation · 2019
  • K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureDemetech Corporation · 2019
  • K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation · 2018
  • K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation · 2018

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/K201479 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201479: DemeMASK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201479

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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