510(k) · Cleared
ClearedCrosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crosstex Intl. · FXX Mask, Surgical
Cleared on Jan 22, 2002 as substantially equivalent to K801036 (American Threshold Industries, Inc., 1980) and 1 other predicate after a 162-day review. Its family tree reaches back 2 generations to 1987. 28 later devices descend from it.
- Decided
- Jan 22, 2002
- Review
- 162 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). 28 later devices descend from it, 5 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 deviceK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- Descendant · cites it directly · 21 of its ownK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
- Descendant · 2 generations on · 20 of its ownK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
- Descendant · cites it directly · 9 of its ownK092580 Tidi FacemaskTidi Products,Llc · 2010
- Descendant · 2 generations on · 6 of its ownK061864 Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540…Dukal Corp. · 2006
- Descendant · 3 generations on · 4 of its ownK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K040333Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without…Valumax Intl., Inc. · 2004 · cites it directly21descendants
- K051291Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · 2 generations on20descendants
- K092580Tidi FacemaskTidi Products,Llc · 2010 · cites it directly9descendants
- K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp. · 2006 · 2 generations on6descendants
- K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011 · 3 generations on4descendants
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) | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| +1 | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or… | Valumax Intl., Inc. | 2004 | — |
| +2 | K051291 | Non-Sterile Surgical Mask | A.R. Medicom, Inc. | 2005 | 5 |
| +1 | K092580 | Tidi Facemask | Tidi Products,Llc | 2010 | — |
| +2 | K061864 | Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with… | Dukal Corp. | 2006 | — |
| +3 | K111559 | Surgical Masks | Shanghai Neo-Medical Import & Export Co., Ltd. | 2011 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 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…s — Blue Crosstex® Ultra Fluid Resistant No-Fog® Face Masks with Splash Visor - Blue Predicate Device Information: a. American Threshold Industries, Surgical Masks, K# 801036, Asheville, North Carolina Page 1 of 3 b. American Threshold Industries, Fluid Resistant Masks, K# 955556, Enka,… | 1980 |
| * | K955556 | Fluid Resistant MaskSummary page 2…rican Threshold Industries, Surgical Masks, K# 801036, Asheville, North Carolina Page 1 of 3 b. American Threshold Industries, Fluid Resistant Masks, K# 955556, Enka, North Carolina Device Description: The seven (7) Crosstex® Surgical Masks are constructed of either an inner/outer facin… | 1996 |
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without… | 2004 | 21 |
| K092580 | Tidi Facemask | 2010 | 9 |
| K100846 | Imc Surgical Face Mask | 2010 | 3 |
| K050689 | Surgical Face Mask | 2005 | 0 |
| K023755 | Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with Shield | 2003 | 0 |
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 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K040333 (Valumax Intl., Inc., 2004) has gone furthest, with 21 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.
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012602: Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012602
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026