510(k) · Cleared
ClearedActiprotect UF N95 Respirator, Double Strap, Flat Fold
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 Jul 1, 2009 as substantially equivalent to K070782 (Survivair Respirators, LLC, 2007) after a 359-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Jul 1, 2009
- Review
- 359 days
- Class
- Class II
- Product code
- ONT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922507 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
- 5 generations backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
- 4 generations backK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
- 3 generations backK051182 Inovel Health Care Model N95 Particulate Respirators and Surgical…Inovel, LLC · 2005 · Recalled
- 2 generations backK070139 Willson One-Fit Healthcare Particle Respirator and Surgical Mask…Survivair, Inc. · 2007
- 1 generation backK070782 Willson One-Fit Flat-Fold Healthcare Particulate Respirator and…Survivair Respirators, LLC · 2007
- This deviceK081923 Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare · 2009
- Descendant · cites it directly · 0 of its ownK093189 Actiprotect UC N95 RespiratorGlaxosmithkline Consumer Healthcare · 2010
- Descendant · cites it directly · 0 of its ownK093161 Actiprotect UF N95 RespiratorGlaxosmithkline Consumer Healthcare · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −5 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| −4 | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Co. | 2004 | — |
| −3 | K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | Inovel, LLC | 2005 | 1 |
| −2 | K070139 | Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 | Survivair, Inc. | 2007 | — |
| −1 | K070782 | Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask… | Survivair Respirators, LLC | 2007 | — |
| 0 (this device) | K081923 | Actiprotect UF N95 Respirator, Double Strap, Flat Fold | Glaxosmithkline Consumer Healthcare | 2009 | — |
| +1 | K093189 | Actiprotect UC N95 Respirator | Glaxosmithkline Consumer Healthcare | 2010 | — |
| +1 | K093161 | Actiprotect UF N95 Respirator | Glaxosmithkline Consumer Healthcare | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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 |
|---|---|---|---|
| * | K070782 | Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models…Summary page 2…vice is Substantially Equivalent: Willson ONE-Fit Flat Folded Healthcare Particulate Respirator and Surgical Mask Model HC-NBO95F & HC-NB295F (K070782). 6.5 Device Description: ActiprotectTm UF N95 Respirator is a double strap, flat-fold style fil… | 2007 |
What descends from it? (2)
2 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 17 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K093189 (Glaxosmithkline Consumer Healthcare, 2010) has gone furthest, with 0 descendants of its own.
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. 2009, 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?
ActiprotectTM UF N95 Respirator is a single use, disposable respirator coated with VirucoatTM on the outer layer (active ingredient: citric-acid, .1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill…
Read the full statement (203 words)
ActiprotectTM UF N95 Respirator is a single use, disposable respirator coated with VirucoatTM on the outer layer (active ingredient: citric-acid, .1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2/JP/305157), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. ActiprotectTM 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. ActiprotectTM UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081923
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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