510(k) · Cleared
ClearedCrosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crosstex International · FXX Mask, Surgical
Cleared on Oct 16, 2008 as substantially equivalent to K801036 (American Threshold Industries, Inc., 1980) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1987. 299 later devices descend from it.
- Decided
- Oct 16, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K874608 (1987). 4 ancestors in all, the oldest K801036 (1980). 299 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 1 generation backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- This deviceK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- Descendant · cites it directly · 289 of its ownK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- Descendant · 2 generations on · 262 of its ownK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- Descendant · 2 generations on · 185 of its ownK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- Descendant · 3 generations on · 170 of its ownK133070 SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015
- Descendant · 4 generations on · 158 of its ownK153496 Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016
Showing 5 of 299 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 299 · See all- K110455Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011 · cites it directly289descendants
- K111402KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Kimberly-Clark · 2011 · 2 generations on262descendants
- K131879KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · 2 generations on185descendants
- K133070SURGICAL FACE MASK (Ear Loops and Tie-on)Bh Medical Products Co., Ltd. · 2015 · 3 generations on170descendants
- K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 2016 · 4 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −1 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| 0 (this device) | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| +1 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| +2 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| +2 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| +3 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | Bh Medical Products Co., Ltd. | 2015 | — |
| +4 | K153496 | Disposable Surgical Face Mask | Xiantao Rayxin Medical Products Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 15 | 0 |
| 2021 | 156 | 0 |
| 2022 | 72 | 0 |
| 2023 | 17 | 0 |
| 2024 | 13 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K801036 | Surgical MaskSummary page 1…t No-Fog® Face Masks with Splash Visor - Blue 3. Predicate Device Information: a. American Threshold Industries, Surgical Masks, K# 801036, Asheville, North Carolina. b. American Threshold Industries, Fluid Resistant Masks, K# 955556, Enka,… | 1980 |
| * | K955556 | Fluid Resistant MaskSummary page 1…American Threshold Industries, Surgical Masks, K# 801036, Asheville, North Carolina. b. American Threshold Industries, Fluid Resistant Masks, K# 955556, Enka, North Carolina. 4. Device Description: The seven (7) Crosstex® Surgical Masks are co… | 1996 |
What descends from it? (299)
See all 2994 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 21 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K110455 (Kimberly-Clark Corp., 2011) has gone furthest, with 289 descendants of its own.
- 1 other device also cites its predicate K801036.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. * Crosstex® Isolite® Earloop Face Masks - Blue, Pink * Crosstex® Isofluid® Earloop Face Masks - Blue, Pink, White, Green * Crosstex® Isofluid FogFree® Earloop Face Masks - Blue, Peach * Crosstex® Isofluid FogFree® Face…
Read the full statement (111 words)
The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
* Crosstex® Isolite® Earloop Face Masks - Blue, Pink
* Crosstex® Isofluid® Earloop Face Masks - Blue, Pink, White, Green
* Crosstex® Isofluid FogFree® Earloop Face Masks - Blue, Peach
* Crosstex® Isofluid FogFree® Face Masks with Splash Visor - Blue, Peach
* Crosstex® Procedural Earloop Face Masks - Blue, Pink, Yellow
* Crosstex® Ultra Fluid Resistant No-Fog® Earloop Face Masks - Blue
* Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor - Blue
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082258: Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face Masks with and Without Splash Visor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082258
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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