510(k) · Cleared
ClearedInsta-Gard Surgical and Procedure Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health200, LLC · FXX Mask, Surgical
Cleared on Mar 4, 2015 as substantially equivalent to K110455 (Kimberly-Clark Corp., 2011) after a 139-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Mar 4, 2015
- Review
- 139 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K874608 (1987). 6 ancestors in all, the oldest K801036 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 3 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 2 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 1 generation backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- This deviceK142990 Insta-Gard Surgical and Procedure Face MaskCardinal Health200, LLC · 2015
- Descendant · cites it directly · 0 of its ownK203265 nPro Surgical MaskNp Medical, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K203265nPro Surgical MaskNp Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −3 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K142990 | Insta-Gard Surgical and Procedure Face Mask | Cardinal Health200, LLC | 2015 | — |
| +1 | K203265 | nPro Surgical Mask | Np Medical, Inc. | 2021 | — |
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 |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face MasksSummary page 4…847) 785-2461 December 31, 2014 Insta-Gard® Surgical Mask Insta-Gard® Procedure Mask Class Il per 21 CFR § 878.4040 Surgical Apparel Surgical Mask Procedure Mask FXX K110455 —Kimberly-Clark, KC100 Face Mask(s) Description The Cardinal Health Insta-Gard® surgical and procedure masks are… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203265 | nPro Surgical Mask | 2021 | 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 28 years and passes through 5 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K203265 (Np Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K110455.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Cardinal Health Insta-Gard® surgical and procedure mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile. This submission covers 15 catalog numbers of Insta-Gard®…
Read the full statement (104 words)
Cardinal Health Insta-Gard® surgical and procedure mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
This submission covers 15 catalog numbers of Insta-Gard® surgical and procedure masks models, see Table 1 below. Each model is a three-layer mask of varying composition and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and meets Level 1 criteria.
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/K142990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142990: Insta-Gard Surgical and Procedure Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142990
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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