510(k) · Cleared
ClearedPleats Plus N95 Particulate Respirator, Models 1050 and 1050S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aearo Co. · MSH Respirator, Surgical
Cleared on Nov 10, 2004 as substantially equivalent to K960778 (Louis M. Gerson Co., Inc., 1996) after a 124-day review. Its family tree reaches back 2 generations to 1992. 15 later devices descend from it.
- Decided
- Nov 10, 2004
- Review
- 124 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922507 (1992). 15 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
- 1 generation backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
- This deviceK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
- Descendant · cites it directly · 11 of its ownK051182 Inovel Health Care Model N95 Particulate Respirators and Surgical…Inovel, LLC · 2005 · Recalled
- 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 · 2 generations on · 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
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K051182Inovel Health Care Model N95 Particulate Respirators and Surgical MasksInovel, LLC · 2005 · cites it directly11descendants
- 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 · 2 generations on3descendants
- K081923Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare · 2009 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −1 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| 0 (this device) | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Co. | 2004 | — |
| +1 | K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | Inovel, LLC | 2005 | 1 |
| +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 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 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? (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 |
|---|---|---|---|
| * | K960778 | Isolair Apr Type N95Summary page 2…e 5. Copies of tre test reports are in the appendix. Pleats Plus N95 Respirators are substantially equivalent to the Gerson isolair APR, type N95. Model 2735, 510(k) K960778, which is marketed for use as a Surgical Mask. Acaro Company 510(k) 8/31/04… | 1996 |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | 2005 | 11 |
| K070139 | Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 | 2007 | 5 |
| K090131 | DS N95 Surgical Masks and Flat Surgical | 2009 | 0 |
| K080827 | Handan N95 Particulate Respirators and Surgical Mask, Models HY8510 and HY9810 | 2008 | 0 |
| K072067 | N95 Surgical Respirator, Type AP0018 and AP0028 | 2008 | 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 12 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051182 (Inovel, LLC, 2005) has gone furthest, with 11 descendants of its own.
- 7 other devices also cite its predicate K960778.
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 Pleats PlusTM 1050 and 1050S N95 Respirators and Surgical Masks are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041855
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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