510(k) · Cleared
ClearedActiprotect UF N95 Respirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glaxosmithkline Consumer Healthcare · ONT N95 Respirator With Antimicrobial/Antiviral Agent
Cleared on May 10, 2010 as substantially equivalent to K081923 (Glaxosmithkline Consumer Healthcare, 2009) after a 216-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- May 10, 2010
- Review
- 216 days
- Class
- Class II
- Product code
- ONT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K922507 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
- 6 generations backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
- 5 generations backK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
- 4 generations backK051182 Inovel Health Care Model N95 Particulate Respirators and Surgical…Inovel, LLC · 2005 · Recalled
- 3 generations backK070139 Willson One-Fit Healthcare Particle Respirator and Surgical Mask…Survivair, Inc. · 2007
- 2 generations backK070782 Willson One-Fit Flat-Fold Healthcare Particulate Respirator and…Survivair Respirators, LLC · 2007
- 1 generation backK081923 Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare · 2009
- This deviceK093161 Actiprotect UF N95 RespiratorGlaxosmithkline Consumer Healthcare · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −6 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| −5 | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Co. | 2004 | — |
| −4 | K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | Inovel, LLC | 2005 | 1 |
| −3 | K070139 | Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 | Survivair, Inc. | 2007 | — |
| −2 | K070782 | Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask… | Survivair Respirators, LLC | 2007 | — |
| −1 | K081923 | Actiprotect UF N95 Respirator, Double Strap, Flat Fold | Glaxosmithkline Consumer Healthcare | 2009 | — |
| 0 (this device) | K093161 | Actiprotect UF N95 Respirator | Glaxosmithkline Consumer Healthcare | 2010 | — |
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? (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 |
|---|---|---|---|
| * | K081923 | Actiprotect UF N95 Respirator, Double Strap, Flat FoldSummary page 2…Product Code ONT 6.4 Devices to Which New Device is Substantially Equivalent: ActiprotectTM UF N95 Respirator KO081923 6.5 Device Description: Actiprotect"M UF N95 Respirator is a double strap, flat-fold style f… | 2009 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K081923.
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. 2010, 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?
Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: Uitric acid, 1.8%, a pH lowering agent) and is not an antiviral ding. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes HI NI (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99%…
Read the full statement (224 words)
Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: Uitric acid, 1.8%, a pH lowering agent) and is not an antiviral ding. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes HI NI (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): HININ(JPN/35/2007, YPN/36/2007, including 2009 pandemnic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: HSNlI (VNH5N1I-PR8/CDCRG), H5N9 (Turkey AIWisc/68, Myna AIMass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UP N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
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/K093161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093161: Actiprotect UF N95 Respirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093161
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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