510(k) Report

510(k) · Cleared

Cleared

Innonix Antiviral Child's Face Mask

K192105510(k) TraditionalCleared Nov 29, 2019116-day reviewClass II21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Innonix Technologies Limited · OUK Surgical Mask With Antimicrobial/Antiviral Agent

Cleared on Nov 29, 2019 as substantially equivalent to K101128 (Filligent Limited, 2011) after a 116-day review. Its family tree reaches back 5 generations to 1997.

Decided
Nov 29, 2019
Review
116 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.

  1. Root · 5 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
  2. 4 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
  3. 3 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
  4. 2 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
  5. 1 generation backK101128 Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001…Filligent Limited · 2011
  6. This deviceK192105 Innonix Antiviral Child's Face MaskInnonix Technologies Limited · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K970835Face Mask, Surgical Mask, Non-SterileTucker & Associates1997—
−4K022256Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates2004—
−3K060776Surgical Face MaskHong YA Non-Woven Products Co., Ltd.2006—
−2K061716Prestige Ameritech Face MaskPrestige Ameritech2006—
−1K101128Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium…Filligent Limited2011—
0 (this device)K192105Innonix Antiviral Child's Face MaskInnonix Technologies Limited2019—
FIG. 1 — Lineage of K192105, 1997–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K101128Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013
Summary page 4
…ate Device: Device Name 510(k) Number K101128 Primary Predicate: BioFriend™ BioMask™Surgical…
Filligent Limited2011—
†K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech2016—

Also cleared against K101128: 2 other devices →

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 devices

OUK 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

2011: 12019: 22024: 1
2007high 2 (2019) · low 0 (2007)2026

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

2017: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code OUK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20192—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—

What is it indicated for?

The Innonix Anti-Influenza Child’s Face Mask (Models BF-200-3015A and BF-200-2005A) is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for…

Read the full statement (270 words)

The Innonix Anti-Influenza Child’s Face Mask (Models BF-200-3015A and BF-200-2005A) is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Innonix Anti-Influenza Child’s Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6% and zinc 1.6%) that inactivate influenza viruses.

The Innonix Anti-Influenza Child’s Face Mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of 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 H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/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). The mask also inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact with the surface of the facemask in laboratory in vitro tests. Correlation between in vitro results and any clinical event has not been tested.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K192105: Innonix Antiviral Child's 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/K192105

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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