510(k) · Cleared
ClearedFace Mask, Surgical Mask, Procedure Mask, Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tiger Medical Products, Ltd. · FXX Mask, Surgical
Cleared on Dec 21, 2012 as substantially equivalent to K061716 (Prestige Ameritech, 2006) after a 107-day review. Its family tree reaches back 4 generations to 1997. 45 later devices descend from it.
- Decided
- Dec 21, 2012
- Review
- 107 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970835 (1997). 45 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 3 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 2 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 1 generation backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- This deviceK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
- Descendant · cites it directly · 35 of its ownK173062 Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018
- Descendant · 2 generations on · 17 of its ownK201479 DemeMASKDemetech Corporation · 2020
- Descendant · cites it directly · 7 of its ownK153409 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016
- Descendant · 2 generations on · 5 of its ownK202843 Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2021
- Descendant · 3 generations on · 4 of its ownK210030 Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd. · 2021
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation · 2018 · cites it directly35descendants
- K201479DemeMASKDemetech Corporation · 2020 · 2 generations on17descendants
- K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016 · cites it directly7descendants
- K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2021 · 2 generations on5descendants
- K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd. · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −3 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −2 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −1 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| 0 (this device) | K122717 | Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask | Tiger Medical Products, Ltd. | 2012 | — |
| +1 | K173062 | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) | V&Q Manufacturing Corporation | 2018 | — |
| +2 | K201479 | DemeMASK | Demetech Corporation | 2020 | — |
| +1 | K153409 | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) | Protect U Guard, LLC | 2016 | — |
| +2 | K202843 | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2021 | — |
| +3 | K210030 | Medical Surgical Mask | Tianjin Aoshang Outdoor Equipment Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 29 | 0 |
| 2022 | 7 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K061716 | Prestige Ameritech Face MaskSummary page 1…protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. 7. SE Comparison to Predicate Device: K061716 - Prestige Ameritech Face Mask K122717 Tiger Medical - SUMMARY… | 2006 |
What descends from it? (45)
See all 453 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 15 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K173062 (V&Q Manufacturing Corporation, 2018) has gone furthest, with 35 descendants of its own.
- 4 other devices also cite its predicate K061716.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 following surgical masks are intended for single use by operating room personnel and
other general healthcare workers to protect both patients and healthcare workers against
transfer of microorganisms, blood and body fluids, and airborne particulates.
-face mask (earloop)
-face mask (tie-on)
-surgical mask (earloop)
-surgical mask (tie-on)
-surgical face mask (earloap)
-surgical face mask (tie-on)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122717: Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122717
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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