510(k) Report

510(k) · Cleared

Cleared

Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560

K061864510(k) TraditionalCleared Sep 15, 200674-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

Dukal Corp. · FXX Mask, Surgical

Cleared on Sep 15, 2006 as substantially equivalent to K051291 (A.R. Medicom, Inc., 2005) and 1 other predicate after a 74-day review. Its family tree reaches back 5 generations to 1987. 6 later devices descend from it.

Decided
Sep 15, 2006
Review
74 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). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1980: 1 other ancestor1991: 1 other ancestor2007: 1 descendant cleared2011: 1 descendant cleared2020: 1 descendant cleared2021: 3 descendants 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: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant 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 deviceK061864 Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540…Dukal Corp. · 2006
  7. Descendant · cites it directly · 4 of its ownK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
  8. Descendant · 2 generations on · 3 of its ownK201137 Asept Surgical Face MaskPfm Medical, Inc. · 2020
  9. Descendant · 3 generations on · 1 of its ownK203200 Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021
  10. Descendant · 4 generations on · 0 of its ownK210643 Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021
  11. Descendant · 3 generations on · 0 of its ownK203174 Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd. · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12011: 12020: 12021: 3
2007high 3 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011 · cites it directly4descendants
  • K201137Asept Surgical Face MaskPfm Medical, Inc. · 2020 · 2 generations on3descendants
  • K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021 · 3 generations on1descendant
  • K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021 · 4 generations on0descendants
  • K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd. · 2021 · 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)K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with…Dukal Corp.2006—
+1K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd.2011—
+2K201137Asept Surgical Face MaskPfm Medical, Inc.2020—
+3K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd.2021—
+4K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd.2021—
+3K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199110
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
202010
202130
FIG. 1 — Lineage of K061864, 1987–2021Source: 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
*K051291Non-Sterile Surgical Mask
Summary page 1
…ized Performance Standard: ASTM 2100-04 Refer to submission for applicable standards Predicate Devices 510(k) Number 1. A.R. Medicom K051291 2. ValuMax International (K040333 1 K061 8…
A.R. Medicom, Inc.20055
*K040333Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without…
Summary page 1
…Refer to submission for applicable standards Predicate Devices 510(k) Number 1. A.R. Medicom K051291 2. ValuMax International (K040333 1 K061 864 Intended Use: The Dukal medical / surgica…
Valumax Intl., Inc.2004—

Also cleared against K051291: 6 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd.20114
K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop…Dukal Corp.20070

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 19 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K111559 (Shanghai Neo-Medical Import & Export Co., Ltd., 2011) has gone furthest, with 4 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.

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 Dukal medical / surgical mussks are indicated as a protective nose and mouth coveting for healthcare workers and patients involved in medical aud surgical procedures. The masks are indi-:rled in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

This covers our current catalog numbers (these numbers can, change with updated revisions to the catdlog):

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
  • K092580Tidi FacemaskTidi Products,Llc · 2010
  • K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop, Shield, Yellow…Dukal Corp. · 2007

More from Dukal Corp.

11 FDA decisions under this applicant name. See the company

  • K083320Dukal Surgical Drape; Fenestrated Dukal Surgical DrapeDukal Corp. · 2009
  • K070407Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop, Shield, Yellow…Dukal Corp. · 2007
  • K020726Dukal Disposable Vaginal Speculum, Small, Medium, and LargeDukal Corp. · 2002
  • K984564Ethyl Chloride DispenserDukal Corp. · 1999
  • K970457Dukal Abd Combine PadDukal Corp. · 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/K061864 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061864: Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061864

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