510(k) · Cleared
ClearedProtect U Guard Earloop and Tie-On Mask (Blue, White or Green)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protect U Guard, LLC · FXX Mask, Surgical
Cleared on Nov 15, 2016 as substantially equivalent to K122717 (Tiger Medical Products, Ltd., 2012) after a 356-day review. Its family tree reaches back 5 generations to 1997. 7 later devices descend from it.
- Decided
- Nov 15, 2016
- Review
- 356 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970835 (1997). 7 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 4 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 3 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 2 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 1 generation backK122717 Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskTiger Medical Products, Ltd. · 2012
- This deviceK153409 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC · 2016
- Descendant · cites it directly · 2 of its ownK201622 Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK231155 Biodegradable Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK213450 Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK203388 Disposable medical maskEverwin Toys (Dongguan)., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK201095 Sovereign America Surgical Face MaskHomtex, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201622Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020 · cites it directly2descendants
- K231155Biodegradable Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2023 · 2 generations on0descendants
- K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 2 generations on0descendants
- K203388Disposable medical maskEverwin Toys (Dongguan)., Ltd. · 2021 · cites it directly0descendants
- K201095Sovereign America Surgical Face MaskHomtex, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −4 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −3 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −2 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −1 | K122717 | Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask | Tiger Medical Products, Ltd. | 2012 | — |
| 0 (this device) | K153409 | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) | Protect U Guard, LLC | 2016 | — |
| +1 | K201622 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020 | — |
| +2 | K231155 | Biodegradable Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023 | — |
| +2 | K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +1 | K203388 | Disposable medical mask | Everwin Toys (Dongguan)., Ltd. | 2021 | — |
| +1 | K201095 | Sovereign America Surgical Face Mask | Homtex, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K122717 | Face Mask, Surgical Mask, Procedure Mask, Surgical Face MaskSummary page 7…e Drive Suite 319 Safety Harbor, FL 34695 (813) 815-0530 7. Comparison to Predicate Device: Predicate Device: Tiger Medical Products Earloop and Tie On Mask (K122717) Description Our Device (K153409) Predicate Device (K122717) Materials… | 2012 |
What descends from it? (7)
5 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 19 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K201622 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K122717.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Earloop Mask and Tie-On Mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile.
Earloop Models: Blue (P10031), White (P10032), or Green (P10033)
Tie-On Models: Blue (P10041), White (P10042), or Green (P10043)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153409 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153409: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153409
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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