510(k) · Cleared
ClearedSurgical Face Mask, Type: Tie-on, Ear-Loop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modern Healthcare Corp. · FXX Mask, Surgical
Cleared on Mar 21, 2007 as substantially equivalent to K060776 (Hong YA Non-Woven Products Co., Ltd., 2006) after a 169-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Mar 21, 2007
- Review
- 169 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970835 (1997). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 2 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 1 generation backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- This deviceK063043 Surgical Face Mask, Type: Tie-on, Ear-LoopModern Healthcare Corp. · 2007
- Descendant · cites it directly · 2 of its ownK123115 Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/PAcme Filter Mask, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK201549 Motex Anti-Fog Surgical Face MaskModern Healthcare Corp. · 2020
- Descendant · 2 generations on · 0 of its ownK203376 ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model…Medtecs (Taiwan) Corp. · 2022
- Descendant · 2 generations on · 0 of its ownK212863 Surgical Face MaskTaiwan Comfort Champ Manufacturing Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK202126 Disposable Surgical MaskShenzhen Peninsula Medical Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K123115Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/PAcme Filter Mask, Inc. · 2013 · cites it directly2descendants
- K201549Motex Anti-Fog Surgical Face MaskModern Healthcare Corp. · 2020 · cites it directly1descendant
- K203376ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400GMedtecs (Taiwan) Corp. · 2022 · 2 generations on0descendants
- K212863Surgical Face MaskTaiwan Comfort Champ Manufacturing Co., Ltd. · 2022 · 2 generations on0descendants
- K202126Disposable Surgical MaskShenzhen Peninsula Medical Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −2 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −1 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| 0 (this device) | K063043 | Surgical Face Mask, Type: Tie-on, Ear-Loop | Modern Healthcare Corp. | 2007 | — |
| +1 | K123115 | Acme Surgical Face Mask with Ear-Loop Model YN-501 AB/W/G/P | Acme Filter Mask, Inc. | 2013 | — |
| +1 | K201549 | Motex Anti-Fog Surgical Face Mask | Modern Healthcare Corp. | 2020 | — |
| +2 | K203376 | ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number… | Medtecs (Taiwan) Corp. | 2022 | — |
| +2 | K212863 | Surgical Face Mask | Taiwan Comfort Champ Manufacturing Co., Ltd. | 2022 | — |
| +2 | K202126 | Disposable Surgical Mask | Shenzhen Peninsula Medical Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
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 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060776 | Surgical Face MaskSummary page 1…e: Surgical Face Mask, Type: lie-on, Ear-loop * Common name of device: Surgical Face Mask Disposable * Predicate Device: Surgical Face Mask, K060776 * Official Correspondent: Dr. Jen, Ke-Min E-mail: ceirs.ien(gmsa.hint.net (Tel) 886-3-5208829; (Fax) 886-3-… | 2006 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 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, K123115 (Acme Filter Mask, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K060776.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.
This Surgical Face Mask is non-sterilized and disposable for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063043 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063043: Surgical Face Mask, Type: Tie-on, Ear-Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063043
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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