510(k) · Cleared
ClearedSecure-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 Jun 20, 2014 as substantially equivalent to K111402 (Kimberly-Clark, 2011) after a 149-day review. Its family tree reaches back 5 generations to 1987. 4 later devices descend from it.
- Decided
- Jun 20, 2014
- Review
- 149 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K874608 (1987). 7 ancestors in all, the oldest K801036 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 4 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 3 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 2 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 1 generation backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- This deviceK140155 Secure-Gard Surgical and Procedure Face MaskCardinal Health200, LLC · 2014
- Descendant · cites it directly · 3 of its ownK192374 Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripCardinal Health200, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK211762 Altor Safety 4-Ply Surgical Mask (Model:62232)Altor Safety, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK221209 PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsPadm Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK201732 Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal…Dukal Corporation · 2021
Most influential descendants
Showing 4 of 4 · See all- K192374Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam StripCardinal Health200, LLC · 2019 · cites it directly3descendants
- K211762Altor Safety 4-Ply Surgical Mask (Model:62232)Altor Safety, LLC · 2021 · 2 generations on1descendant
- K221209PRECISION ECO Compostable / Plant Based Procedural Mask with EarloopsPadm Medical, Inc. · 2023 · 3 generations on0descendants
- K201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3…Dukal Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −4 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −3 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −2 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −1 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| 0 (this device) | K140155 | Secure-Gard Surgical and Procedure Face Mask | Cardinal Health200, LLC | 2014 | — |
| +1 | K192374 | Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip | Cardinal Health200, LLC | 2019 | — |
| +2 | K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) | Altor Safety, LLC | 2021 | — |
| +3 | K221209 | PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops | Padm Medical, Inc. | 2023 | — |
| +2 | K201732 | Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation… | Dukal Corporation | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300…Summary page 1…ommon Name: Surgical Mask Procedure Mask Product Code: FXX Predicate Device: K1 11402 -Kimberly-C lark, KC300 Face Mask(s) Description The Cardinal Health Secure-Gard" surgical and procedure masks a… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192374 | Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip | 2019 | 3 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K192374 (Cardinal Health200, LLC, 2019) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K111402.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Secure-Garde surgical and procedure masks are 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 Secure-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140155: Secure-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/K140155
Report an extraction error
Are you the manufacturer?
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