510(k) · Cleared
ClearedBiofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Filligent Limited · OUK Surgical Mask With Antimicrobial/Antiviral Agent
Cleared on May 26, 2011 as substantially equivalent to K061716 (Prestige Ameritech, 2006) after a 399-day review. Its family tree reaches back 4 generations to 1997. 4 later devices descend from it.
- Decided
- May 26, 2011
- Review
- 399 days
- Class
- Class II
- Product code
- OUK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970835 (1997). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 3 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 2 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 1 generation backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- This deviceK101128 Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001…Filligent Limited · 2011
- Descendant · cites it directly · 1 of its ownK122702 Biofriend Biomask N95 Surgical RespiratorFilligent Limited · 2013
- Descendant · cites it directly · 0 of its ownK192105 Innonix Antiviral Child's Face MaskInnonix Technologies Limited · 2019
- Descendant · cites it directly · 0 of its ownK182766 Cufitec Surgical MaskNbc Meshtec, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK150729 SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K122702Biofriend Biomask N95 Surgical RespiratorFilligent Limited · 2013 · cites it directly1descendant
- K192105Innonix Antiviral Child's Face MaskInnonix Technologies Limited · 2019 · cites it directly0descendants
- K182766Cufitec Surgical MaskNbc Meshtec, Inc. · 2019 · cites it directly0descendants
- K150729SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −3 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −2 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −1 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| 0 (this device) | K101128 | Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium… | Filligent Limited | 2011 | — |
| +1 | K122702 | Biofriend Biomask N95 Surgical Respirator | Filligent Limited | 2013 | — |
| +1 | K192105 | Innonix Antiviral Child's Face Mask | Innonix Technologies Limited | 2019 | — |
| +1 | K182766 | Cufitec Surgical Mask | Nbc Meshtec, Inc. | 2019 | — |
| +2 | K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 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 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 |
|---|---|---|---|
| * | K061716 | Prestige Ameritech Face MaskSummary page 1…Which New Device is Substantially Equivalent Device Name: Prestige Ameritech Face Mask Manufacturer: Prestige Ameritech Reference: K061716 (g)fiiligent- iolriend"' iolask"'Surgical Facemask 5.5… | 2006 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122702 (Filligent Limited, 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K061716.
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. 2011, 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 BioFriendTM BioMaskTM surgical facemasks are single use disposable devices with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w, which form ionic bonds with negatively-charged side-groups on influenza viruses). The BioFriendTM BioMaskTM surgical facemasks inactivate 99.99% of Influenza…
Read the full statement (254 words)
The BioFriendTM BioMaskTM surgical facemasks are single use disposable devices with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w, which form ionic bonds with negatively-charged side-groups on influenza viruses).
The BioFriendTM BioMaskTM surgical facemasks inactivate 99.99% of Influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: influenza A subtypes and strains: HiNi (the 2009 pandemnic flu subtype N/California/07/09, A/Brisbane/59/2007, A/Wisconsin/i 0/98, A/New Jersey/8/76, A/PR/8/38), H3N2 (A/Brisbane/i 0/2007,A/Wisconsin/67/2005,), H2N2 (A/2/JAPAN/305/57); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (AfTurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: HiNi (A/Swine/1976/31); the equine flu subtype: H3N8 (N/Equine/2/Miami/63); and Influenza B strains: (B/Florida/4/2006, B/Lee/40), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.
There are two models: (1) Universal (BF-200-2001 A) - a standard flat mask with pleats; (2) Premium (BF-200-301 3A) - flat-folded and expanding into a convex-shaped mask with ear adjusters and an anti-fog nose flap. No clinical studies have been conducted comparing the ability of an untreated facemask and these facemasks to protect the wearer from Influenza infection. They are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of microorganisms, body fluids and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101128: Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101128
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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