510(k) · Cleared
ClearedUnico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unicoglobal, Inc. · FXX Mask, Surgical
Cleared on Dec 22, 2021 as substantially equivalent to K191355 (3M Healthcare, 2019) after a 335-day review. Its family tree reaches back 7 generations to 1987. 1 later device descends from it.
- Decided
- Dec 22, 2021
- Review
- 335 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K874608 (1987). 9 ancestors in all, the oldest K801036 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 6 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 5 generations backK082258 Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid…Crosstex International · 2008
- 4 generations backK110455 Kimberly-Clark Low Barrier, Astm 2100 Face MasksKimberly-Clark Corp. · 2011
- 3 generations backK111402 KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask…Kimberly-Clark · 2011
- 2 generations backK131879 KC 300 Surgical MaskKimberly-Clark Corp. · 2013 · Recalled
- 1 generation backK191355 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant…3M Healthcare · 2019
- This deviceK210147 Unico High Performance Surgical Mask, Unico High Performance…Unicoglobal, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK222266 Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)Jingzhou Haixin Green Cross Medical Products Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222266Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)Jingzhou Haixin Green Cross Medical Products Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −6 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −5 | K082258 | Crosstex Isolite and Isofluid Earloop Face Masks and Isofluid Fogfree Face… | Crosstex International | 2008 | — |
| −4 | K110455 | Kimberly-Clark Low Barrier, Astm 2100 Face Masks | Kimberly-Clark Corp. | 2011 | — |
| −3 | K111402 | KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield… | Kimberly-Clark | 2011 | — |
| −2 | K131879 | KC 300 Surgical Mask | Kimberly-Clark Corp. | 2013 | 1 |
| −1 | K191355 | 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure… | 3M Healthcare | 2019 | — |
| 0 (this device) | K210147 | Unico High Performance Surgical Mask, Unico High Performance Surgical Mask… | Unicoglobal, Inc. | 2021 | — |
| +1 | K222266 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K191355 | 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure MaskSummary page 4…Class: II • Product Code: FXX 4. Predicate Device • Name of Device: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid- Resistant Procedure Mask (K191355) by 3M Health Care • Common Name: Surgical Mask K210147 - Page 1 of 7 === Page 5 =… | 2019 |
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 |
|---|---|---|---|
| K222266 | Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) | 2022 | 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 34 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K222266 (Jingzhou Haixin Green Cross Medical Products Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K191355.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210147: Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210147
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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