510(k) Report

510(k) · Cleared

Cleared

Prestige Ameritech Face Mask

K061716510(k) AbbreviatedCleared Aug 14, 200656-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

Prestige Ameritech · FXX Mask, Surgical

Cleared on Aug 14, 2006 as substantially equivalent to K022256 (Tucker & Associates, 2004) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1997. 61 later devices descend from it.

Decided
Aug 14, 2006
Review
56 days
Class
Class II
Product code
FXX
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K970835 (1997). 61 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2011: 4 descendants cleared2012: 3 descendants cleared2019: 3 descendants cleared2013: 1 descendant cleared2016: 2 descendants cleared2018: 1 descendant cleared2021: 29 descendants cleared2022: 9 descendants cleared2015: 1 descendant cleared2020: 3 descendants cleared2023: 2 descendants cleared2024: 2 descendants 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 · 2004K060776 · Surgical Face Mask · Hong YA Non-Woven Products Co., Ltd. · 20061995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 16 descendants4 generations forward: 27 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K060776 · 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 · 19970+5
  1. Root · 3 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
  2. 2 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
  3. 1 generation backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
  4. This deviceK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
  5. Descendant · cites it directly · 45 of its ownK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
  6. Descendant · 2 generations on · 35 of its ownK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
  7. Descendant · 3 generations on · 17 of its ownK201479 DemeMASKDemetech Corporation · 2020
  8. Descendant · 2 generations on · 7 of its ownK153409 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016
  9. Descendant · cites it directly · 6 of its ownK103150 Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark · 2011

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2011: 42012: 32013: 12015: 12016: 22018: 12019: 32020: 32021: 292022: 92023: 22024: 22026: 1
2011high 29 (2021) · low 0 (2014)2026

Most influential descendants

Showing 5 of 61 · See all
  • K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012 · cites it directly45descendants
  • K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018 · 2 generations on35descendants
  • K201479DemeMASKDemetech Corporation · 2020 · 3 generations on17descendants
  • K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016 · 2 generations on7descendants
  • K103150Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark · 2011 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970835Face Mask, Surgical Mask, Non-SterileTucker & Associates1997—
−2K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates2004—
−1K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd.2006—
0 (this device)K061716Prestige Ameritech Face MaskPrestige Ameritech2006—
+1K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd.2012—
+2K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation2018—
+3K201479DemeMASKDemetech Corporation2020—
+2K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC2016—
+1K103150Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201140
201230
201310
201510
201620
201810
201930
202030
2021290
202290
202320
202420
202610
FIG. 1 — Lineage of K061716, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green
Summary page 1
…Classification Name: Mask, Surgical Classification Product Code: FXX Regulation Number: 878.4040 Predicate Devices: Tucker and Associates Surgical Face Mask K022256 Hong Ya Non-Woven Products Co. Ltd. Surgical Face Mask K060776…
Tucker & Associates2004—
*K060776Surgical Face Mask
Summary page 1
…0 Predicate Devices: Tucker and Associates Surgical Face Mask K022256 Hong Ya Non-Woven Products Co. Ltd. Surgical Face Mask K060776 KcI7b Device Description: T…
Hong YA Non-Woven Products Co., Ltd.2006—

Also cleared against K022256: 5 other devices →

What descends from it? (61)

See all 61

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

NumberDeviceApplicantDecidedDescendants
K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd.201245
K103150Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark20116
K101128Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013Filligent Limited20114
K090414Spectrashield 9500 Surgical MaskNexera Medical, Inc.20112
K102713Tiger Flat Surgical MaskTiger Medical Products, Ltd.20110

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 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K122717 (Tiger Medical Products, Ltd., 2012) has gone furthest, with 45 descendants of its own.
  • 5 other devices also cite its predicate K022256.

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?

The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue…

Read the full statement (97 words)

The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green,

White, Yellow, Peach

Prestige Ameritech Earloop Surgical Mask with splash shield-Blue

Green, White, Peach

Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink,

White, Yellow

Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green,

White, Peach

Prestige Ameritech Tie on Surgical Mask with splash shield-Blue,

Green, White, Peach

Indications for use as stated in the FDA summary.

Also cleared against K022256

5 other devices cite the same predicate.

  • K102713Tiger Flat Surgical MaskTiger Medical Products, Ltd. · 2011
  • K093901Surgical Face MaskEpard Protective Products, Ltd. · 2010
  • K090131DS N95 Surgical Masks and Flat SurgicalShanghai Dasheng Health Products · 2009
  • K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
  • K043199Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2005

More from Prestige Ameritech

5 FDA decisions under this applicant name. See the company

  • K231741ProGear® Surgical Mask with Oxafence®, Model AV82030Prestige Ameritech · 2024
  • K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech · 2017
  • K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech · 2016
  • K102092Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size Model RP CeriesPrestige Ameritech · 2010

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/K061716 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061716: Prestige Ameritech Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061716

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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