510(k) Report

510(k) · Cleared

Cleared

Tidi Facemask

K092580510(k) TraditionalCleared Feb 23, 2010186-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

Tidi Products,Llc · FXX Mask, Surgical

Cleared on Feb 23, 2010 as substantially equivalent to K051291 (A.R. Medicom, Inc., 2005) and 1 other predicate after a 186-day review. Its family tree reaches back 5 generations to 1987. 9 later devices descend from it.

Decided
Feb 23, 2010
Review
186 days
Class
Class II
Product code
FXX
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K874608 (1987). 8 ancestors in all, the oldest K801036 (1980). 9 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1980: 1 other ancestor1991: 1 other ancestor2010: 2 descendants cleared2015: 1 descendant cleared2020: 1 descendant cleared2021: 3 descendants cleared2016: 1 descendant cleared2022: 1 descendant clearedK874608 · Tecnol Fluid Shield Surgical Mask · Tecnol New Jersey Wound Care, Inc. · 1987K955556 · Fluid Resistant Mask · American Threshold Healthcare · 1996K012602 · Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex · Crosstex Intl. · 2002K040333 · Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without Visors, Ties and Earloops · Valumax Intl., Inc. · 2004K051291 · Non-Sterile Surgical Mask · A.R. Medicom, Inc. · 2005 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K051291 · Non-Sterile Surgical Mask · A.R. Medicom, Inc. · 2005 · recalledK040333 · Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without Visors, Ties and Earloops · Valumax Intl., Inc. · 2004K012602 · Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex · Crosstex Intl. · 2002K955556 · Fluid Resistant Mask · American Threshold Healthcare · 1996K874608 · Tecnol Fluid Shield Surgical Mask · Tecnol New Jersey Wound Care, Inc. · 1987−50
  1. Root · 5 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
  2. 4 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
  3. 3 generations backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
  4. 2 generations backK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
  5. 1 generation backK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
  6. This deviceK092580 Tidi FacemaskTidi Products,Llc · 2010
  7. Descendant · cites it directly · 3 of its ownK141875 Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 2015
  8. Descendant · cites it directly · 3 of its ownK093179 Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010
  9. Descendant · 2 generations on · 2 of its ownK152197 Skypro, SP01 MaskSkypro Medical Supplies Company · 2016
  10. Descendant · 2 generations on · 1 of its ownK202139 Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020
  11. Descendant · 3 generations on · 0 of its ownK213450 Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010: 22015: 12016: 12020: 12021: 32022: 1
2010high 3 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all
  • K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 2015 · cites it directly3descendants
  • K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010 · cites it directly3descendants
  • K152197Skypro, SP01 MaskSkypro Medical Supplies Company · 2016 · 2 generations on2descendants
  • K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020 · 2 generations on1descendant
  • K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K874608Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc.1987—
−4K955556Fluid Resistant MaskAmerican Threshold Healthcare1996—
−3K012602Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face…Crosstex Intl.2002—
−2K040333Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or…Valumax Intl., Inc.2004—
−1K051291Non-Sterile Surgical MaskA.R. Medicom, Inc.20055
0 (this device)K092580Tidi FacemaskTidi Products,Llc2010—
+1K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd.2015—
+1K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company2010—
+2K152197Skypro, SP01 MaskSkypro Medical Supplies Company2016—
+2K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.2020—
+3K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199110
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201510
201610
202010
202130
202210
FIG. 1 — Lineage of K092580, 1987–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K051291Non-Sterile Surgical Mask
Summary page 2
…ROVq0?5go Predicate Devices 510 K Number: 1) A.R. Medicom Non-Sterile Surgical Mask K051291 2) Crosstex Isolite Surgical Mask K012602 Device and Predicate Device Comparison Descrip…
A.R. Medicom, Inc.20055
*K012602Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face…
Summary page 2
…dicate Devices 510 K Number: 1) A.R. Medicom Non-Sterile Surgical Mask K051291 2) Crosstex Isolite Surgical Mask K012602 Device and Predicate Device Comparison Description TIDI® Facemask Predicate:…
Crosstex Intl.2002—

Also cleared against K051291: 6 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd.20153
K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company20103
K100800Tidi FacemaskTidi Products,Llc20100

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 4.4 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K141875 (Pasture Pharma Pte, Ltd., 2015) has gone furthest, with 3 descendants of its own.
  • 6 other devices also cite its predicate K051291.

How does its category compare?

All FXX devices

FXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.

Indications for use as stated in the FDA summary.

Also cleared against K051291

6 other devices cite the same predicate.

  • K212273Cross Protection ResQ300 Plus Surgical Face MaskCross Protection (M) Sdn Bhd · 2022
  • K203425Surgical MaskBdc Dental Corporation, Ltd. · 2021
  • K110027Surgical Face Mask; Surgical Face MaskAngeline Group, Ltd. · 2011
  • K100800Tidi FacemaskTidi Products,Llc · 2010
  • K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop, Shield, Yellow…Dukal Corp. · 2007
  • K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp. · 2006

More from Tidi Products,Llc

3 FDA decisions under this applicant name. See the company

  • K132953TidisheildTidi Products,Llc · 2014
  • K100800Tidi FacemaskTidi Products,Llc · 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/K092580 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092580: Tidi Facemask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092580

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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