510(k) · Cleared
ClearedTriple Layer Fluid-Resistant Molded Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FXX Mask, Surgical
Cleared on Mar 20, 1991 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 331 later devices descend from it.
- Decided
- Mar 20, 1991
- Review
- 69 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 0
331 later devices descend from it, 2 citing it directly.
- This deviceK910110 Triple Layer Fluid-Resistant Molded Face Mask3M Company · 1991
- Descendant · cites it directly · 329 of its ownK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- Descendant · 2 generations on · 299 of its ownK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- Descendant · 3 generations on · 289 of its ownK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- Descendant · 4 generations on · 262 of its ownK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- Descendant · 4 generations on · 185 of its ownK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
Showing 5 of 331 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 331 · See all- K955556Fluid Resistant MaskAmerican Threshold Healthcare · 1996 · cites it directly329descendants
- K082258Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with…Crosstex International · 2008 · 2 generations on299descendants
- K110455Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011 · 3 generations on289descendants
- K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Kimberly-Clark · 2011 · 4 generations on262descendants
- K131879KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · 4 generations on185descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910110 | Triple Layer Fluid-Resistant Molded Face Mask | 3M Company | 1991 | — |
| +1 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| +2 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| +3 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| +4 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| +4 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 17 | 0 |
| 2021 | 165 | 0 |
| 2022 | 75 | 0 |
| 2023 | 17 | 0 |
| 2024 | 13 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (331)
See all 3312 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?
- Of its descendants, K955556 (American Threshold Healthcare, 1996) has gone furthest, with 329 descendants of its own.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K910110 · printed Nov 4, 2026
Cite this page
510(k) Report. “K910110: Triple Layer Fluid-Resistant Molded Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K910110
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026