510(k) Report

510(k) · Cleared

Cleared

Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green

K022256510(k) TraditionalCleared Apr 26, 2004654-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

Tucker & Associates · FXX Mask, Surgical

Cleared on Apr 26, 2004 as substantially equivalent to K970835 (Tucker & Associates, 1997) after a 654-day review. Its family tree reaches back 1 generation to 1997. 77 later devices descend from it.

Decided
Apr 26, 2004
Review
654 days
Class
Class II
Product code
FXX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K970835 (1997). 77 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2006: 2 descendants cleared2011: 4 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2007: 1 descendant cleared2012: 3 descendants cleared2013: 3 descendants cleared2020: 4 descendants cleared2022: 12 descendants cleared2019: 3 descendants cleared2016: 2 descendants cleared2018: 1 descendant cleared2021: 31 descendants cleared2015: 2 descendants cleared2023: 2 descendants cleared2024: 2 descendants cleared2026: 1 descendant clearedK970835 · Face Mask, Surgical Mask, Non-Sterile · Tucker & Associates · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 6 descendants3 generations forward: 12 descendants4 generations forward: 20 descendants5 generations forward: 28 descendants6 generations forward: 4 descendants7 generations forward: 1 descendant K970835 · Face Mask, Surgical Mask, Non-Sterile · Tucker & Associates · 19970+5
  1. Root · 1 generation backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
  2. This deviceK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
  3. Descendant · cites it directly · 73 of its ownK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
  4. Descendant · cites it directly · 61 of its ownK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
  5. Descendant · 2 generations on · 45 of its ownK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
  6. Descendant · 3 generations on · 35 of its ownK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
  7. Descendant · 4 generations on · 17 of its ownK201479 DemeMASKDemetech Corporation · 2020

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 12009: 12010: 22011: 42012: 32013: 32015: 22016: 22018: 12019: 32020: 42021: 312022: 122023: 22024: 22026: 1
2005high 31 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 77 · See all
  • K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006 · cites it directly73descendants
  • K061716Prestige Ameritech Face MaskPrestige Ameritech · 2006 · cites it directly61descendants
  • K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012 · 2 generations on45descendants
  • K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018 · 3 generations on35descendants
  • K201479DemeMASKDemetech Corporation · 2020 · 4 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970835Face Mask, Surgical Mask, Non-SterileTucker & Associates1997—
0 (this device)K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates2004—
+1K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd.2006—
+1K061716Prestige Ameritech Face MaskPrestige Ameritech2006—
+2K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd.2012—
+3K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation2018—
+4K201479DemeMASKDemetech Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200710
200910
201020
201140
201230
201330
201520
201620
201810
201930
202040
2021310
2022120
202320
202420
202610
FIG. 1 — Lineage of K022256, 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 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
*K970835Face Mask, Surgical Mask, Non-Sterile
Summary page 1
…(Multiple Labels) Common Name: Face Mask, Surgical Regulatory Reference: 21 CFR 878. Predicate Device: Face Mask, Surgical Mask, K970835 Labels/Labeling: This device will be marketed to medical device suppliers, Dentist an…
Tucker & Associates1997—

What descends from it? (77)

See all 77

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

NumberDeviceApplicantDecidedDescendants
K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd.200673
K061716Prestige Ameritech Face MaskPrestige Ameritech200661
K102713Tiger Flat Surgical MaskTiger Medical Products, Ltd.20110
K093901Surgical Face MaskEpard Protective Products, Ltd.20100
K090131DS N95 Surgical Masks and Flat SurgicalShanghai Dasheng Health Products20090
K043199Surgical Face MaskHong YA Non-Woven Products Co., Ltd.20050

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?

  • Its one ancestor has no recall.
  • Of its descendants, K060776 (Hong YA Non-Woven Products Co., Ltd., 2006) has gone furthest, with 73 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

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?

This device is intended to be worn to protect both the patient and healthcare personnel From transfer of microorganisms, body fluids and particulate material.

Indications for use as stated in the FDA summary.

More from Tucker & Associates

4 FDA decisions under this applicant name. See the company

  • K980827Latex Finger Cot, Powder-Free, with Protein LabelingTucker & Associates · 1998
  • K980802Nitrile Exam Glove, Powder-Free, BlueTucker & Associates · 1998
  • K970835Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997

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/K022256 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022256: Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022256

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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