510(k) · Cleared
ClearedBiofriend Biomask N95 Surgical Respirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Filligent Limited · ONT N95 Respirator With Antimicrobial/Antiviral Agent
Cleared on Mar 18, 2013 as substantially equivalent to K101128 (Filligent Limited, 2011) and 1 other predicate after a 195-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Mar 18, 2013
- Review
- 195 days
- Class
- Class II
- Product code
- ONT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970835 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK122702 Biofriend Biomask N95 Surgical RespiratorFilligent Limited · 2013
- Descendant · cites it directly · 0 of its ownK150729 SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150729SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc. · 2015 · cites it directly0descendants
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) | K122702 | Biofriend Biomask N95 Surgical Respirator | Filligent Limited | 2013 | — |
| +1 | K150729 | SpectraShield 9500 Surgical N95 Respirator | Nexera Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 ONT? 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? (2)
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 2…nt Device Name: BioFriendM BioMaskTM "Premium" BF-200-3013A (Convex) Manufacturer: Filligent (HK) Limited Reference: K101128 Device Name: BioFriendM BioMaskTM "Universal" BF-200-2001A (Flat) Manufacturer: Filligent (HK)… | 2011 |
| * | K063023 | 3M Health Care Particulate Respirator and Surgical Mask, Model 1870Summary page 2…28 Device Name: 1870 3M N95 Health Care Particulate Respirator and Surgical Mask Manufacturer: 3M Company Reference: K063023 5.5 Device Description The BioFriend T m BioMaskT N95 surgical respirator, Model: Professional (BF-200-3013… | 2007 |
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 |
|---|---|---|---|
| K150729 | SpectraShield 9500 Surgical N95 Respirator | 2015 | 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 16 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150729 (Nexera Medical, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101128.
How does its category compare?
All ONT devicesONT N95 Respirator With Antimicrobial/Antiviral Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ONT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · ONT
Too few ONT 510(k)s in any year since 2007 to give a median.
Recalls per year · ONT
No recall names ONT since 2007.
Adverse event reports per year · ONT
1in 2020
MAUDE reports naming product code ONT, 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 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioFriend BioMask N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator 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 BioFriend BioMask N95 surgical…
Read the full statement (266 words)
The BioFriend BioMask N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator 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 BioFriend BioMask N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes and strains H1N1 (the 2009 pandemic flu subtype A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/Puerto Rico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested.
The BioFriend BioMask N95 surgical respirator, Model: Professional BF-200-3013AN is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122702 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122702: Biofriend Biomask N95 Surgical Respirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122702
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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