510(k) · Cleared
ClearedComfort Guard Mask, level 1, Comfort Guard Mask, level 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gri-Alleset, Inc. · FXX Mask, Surgical
Cleared on Apr 7, 2022 after a 380-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 7, 2022
- Review
- 380 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Non-sterile, single use device designed to create a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. They are designed to be worn in the operating room, dental offices, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microogransims, bodily fluid and particulate matter. Level I surgical Tie Mask,33-3000, 33-3002, 33-3010…
Read the full statement (95 words)
Non-sterile, single use device designed to create a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. They are designed to be worn in the operating room, dental offices, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microogransims, bodily fluid and particulate matter.
Level I surgical Tie Mask,33-3000, 33-3002, 33-3010, 33-3012,33-3020,33-3022, 33-3023, 33-3025,
Level I Procedure Mask,33-2000, 33-2002, 33-2010, 33-2012,33-2020,33-2022, 33-2023, 33-2025,
Level III Surgical Tie Mask,33-3040, 33-3050, 33-3052, 33-3060, 33-3062
Level III Procedure Mask, 33-2030, 33-2031, 33-2032, 33-2033
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210860 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210860: Comfort Guard Mask, level 1, Comfort Guard Mask, level 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026