510(k) · Cleared
ClearedCufitec Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nbc Meshtec, Inc. · OUK Surgical Mask With Antimicrobial/Antiviral Agent
Cleared on Jan 3, 2019 as substantially equivalent to K101128 (Filligent Limited, 2011) after a 97-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jan 3, 2019
- Review
- 97 days
- Class
- Class II
- Product code
- OUK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970835 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 4 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 3 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 2 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 1 generation backK101128 Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001…Filligent Limited · 2011
- This deviceK182766 Cufitec Surgical MaskNbc Meshtec, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −4 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −3 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −2 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −1 | K101128 | Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium… | Filligent Limited | 2011 | — |
| 0 (this device) | K182766 | Cufitec Surgical Mask | Nbc Meshtec, Inc. | 2019 | — |
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 OUK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101128 | Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013Summary page 4…Models: Universal BF 200-2001A, Premium BF-200-3013A Manufacturer Filligent (HK) Limited Reference K101128 NBC Meshtec – Cufitec® Surgical Mask 510(k)… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K101128.
How does its category compare?
All OUK devicesOUK Surgical Mask With Antimicrobial/Antiviral Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OUK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OUK
Too few OUK 510(k)s in any year since 2007 to give a median.
Recalls per year · OUK
No recall names OUK since 2007.
Adverse event reports per year · OUK
1in 2017
MAUDE reports naming product code OUK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and particulates and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers. The Cufitec Surgical Mask inactivates 99.99% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory…
Read the full statement (114 words)
The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and particulates and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers.
The Cufitec Surgical Mask inactivates 99.99% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following influenza viruses:
Influenza A/HIN1: A/WS/33, A/Virginia/ATCC2/2009;
Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ATCC6/2012;
Influenza B: B/Lee/40, B/Taiwan/2/62;
under tested contact conditions.
Correlations between in vitro testing results and any clinical event has not been tested.
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/K182766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182766: Cufitec Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182766
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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