510(k) Report

510(k) · Cleared

Cleared

Face Mask, Surgical Mask, Non-Sterile

K970835510(k) TraditionalCleared Sep 3, 1997196-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 Sep 3, 1997 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 78 later devices descend from it.

Decided
Sep 3, 1997
Review
196 days
Class
Class II
Product code
FXX
Recalls
None
Predicates
0

78 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2010: 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 cleared1995200020052010201520202025
  1. This deviceK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
  2. Descendant · cites it directly · 77 of its ownK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
  3. Descendant · 2 generations on · 73 of its ownK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
  4. Descendant · 2 generations on · 61 of its ownK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
  5. Descendant · 3 generations on · 45 of its ownK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
  6. Descendant · 4 generations on · 35 of its ownK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 22007: 12009: 12010: 22011: 42012: 32013: 32015: 22016: 22018: 12019: 32020: 42021: 312022: 122023: 22024: 22026: 1
2004high 31 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 78 · See all
  • K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004 · cites it directly77descendants
  • K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006 · 2 generations on73descendants
  • K061716Prestige Ameritech Face MaskPrestige Ameritech · 2006 · 2 generations on61descendants
  • K122717Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012 · 3 generations on45descendants
  • K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018 · 4 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200620
200710
200910
201020
201140
201230
201330
201520
201620
201810
201930
202040
2021310
2022120
202320
202420
202610
FIG. 1 — Lineage of K970835, 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (78)

See all 78

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates200477

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?

  • Of its descendants, K022256 (Tucker & Associates, 2004) has gone furthest, with 77 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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Tucker & Associates

4 FDA decisions under this applicant name. See the company

  • K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
  • K980827Latex Finger Cot, Powder-Free, with Protein LabelingTucker & Associates · 1998
  • K980802Nitrile Exam Glove, Powder-Free, BlueTucker & Associates · 1998

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/K970835 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970835: Face Mask, Surgical Mask, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970835

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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