510(k) · Cleared
Recalled · 2006Inovel Health Care Model N95 Particulate Respirators and Surgical Masks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovel, LLC · MSH Respirator, Surgical
Cleared on May 19, 2005 as substantially equivalent to K041855 (Aearo Co., 2004) and 1 other predicate after a 10-day review. Its family tree reaches back 3 generations to 1992. 11 later devices descend from it. It has been recalled once.
- Decided
- May 19, 2005
- Review
- 10 days
- Class
- Class II
- Product code
- MSH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922507 (1992). 11 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
- 2 generations backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
- 1 generation backK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
- This deviceK051182 Inovel Health Care Model N95 Particulate Respirators and Surgical…Inovel, LLC · 2005
- Descendant · cites it directly · 5 of its ownK070139 Willson One-Fit Healthcare Particle Respirator and Surgical Mask…Survivair, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK070782 Willson One-Fit Flat-Fold Healthcare Particulate Respirator and…Survivair Respirators, LLC · 2007
- Descendant · cites it directly · 3 of its ownK061859 Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 2006
- Descendant · 3 generations on · 2 of its ownK081923 Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare · 2009
- Descendant · cites it directly · 1 of its ownK062665 Inovel Health Care N95 Particulate Respirators and Surgical MasksInovel, LLC · 2006
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K070139Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095Survivair, Inc. · 2007 · cites it directly5descendants
- K070782Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models…Survivair Respirators, LLC · 2007 · 2 generations on3descendants
- K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 2006 · cites it directly3descendants
- K081923Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare · 2009 · 3 generations on2descendants
- K062665Inovel Health Care N95 Particulate Respirators and Surgical MasksInovel, LLC · 2006 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −2 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| −1 | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Co. | 2004 | — |
| 0 (this device) | K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | Inovel, LLC | 2005 | — |
| +1 | 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 | K061859 | Inovel Health Care N95 Particulate Respirators & Surgical Masks | Inovel, LLC | 2006 | — |
| +3 | K081923 | Actiprotect UF N95 Respirator, Double Strap, Flat Fold | Glaxosmithkline Consumer Healthcare | 2009 | — |
| +1 | K062665 | Inovel Health Care N95 Particulate Respirators and Surgical Masks | Inovel, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 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 MSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSH device
- #1 K233022 Halyard Fluidshield 3 N95 Particulate Filter…score 6.7 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SSummary page 1…re N95 Particulate Respirators and Surgical Masks are found to be substantially equivalent to the Aearo Co. Pleats Plus mask model 1050 and 1050S [(510(k)K041855] and Gerson Isolair APR type N95 mask model 2735 [5 10(k)K960778)]. These two products have also been tested and approved… | 2004 |
| * | K960778 | Isolair Apr Type N95Summary page 1…substantially equivalent to the Aearo Co. Pleats Plus mask model 1050 and 1050S [(510(k)K041855] and Gerson Isolair APR type N95 mask model 2735 [5 10(k)K960778)]. These two products have also been tested and approved by NIOSH as N95 Respirators. EflO WL… | 1996 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070139 | Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 | 2007 | 5 |
| K061859 | Inovel Health Care N95 Particulate Respirators & Surgical Masks | 2006 | 3 |
| K062665 | Inovel Health Care N95 Particulate Respirators and Surgical Masks | 2006 | 1 |
| K102173 | Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712 | 2010 | 0 |
| K063747 | Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S… | 2007 | 0 |
| K062663 | Moldex Health Care N95 Particulate Respirators and Surgical Masks | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2006 | Not classified | Z-0587-06 | Other | Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K070139 (Survivair, Inc., 2007) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K041855.
How does its category compare?
All MSH devicesMSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MSH
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSH
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSH
10in 2025
MAUDE reports naming product code MSH, 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 | 7 | 78 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 4 | 60 | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The various models of Inovel/Cardinal Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051182: Inovel Health Care Model N95 Particulate Respirators and Surgical Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051182
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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