510(k) · Cleared
ClearedN95 Respirator, Models N9504C, N9504CS and N9514C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aearo Company · MSH Respirator, Surgical
Cleared on Apr 18, 2007 as substantially equivalent to K960778 (Louis M. Gerson Co., Inc., 1996) after a 90-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Apr 18, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922507 (1992). 1 later device descends from it, 1 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 deviceK070168 N95 Respirator, Models N9504C, N9504CS and N9514CAearo Company · 2007
- Descendant · cites it directly · 0 of its ownK072359 Aearo Company Surgical N95 Respirators, Models N9508C and N9511CAearo Company · 2007
Most influential descendants
Showing 1 of 1 · See all- K072359Aearo Company Surgical N95 Respirators, Models N9508C and N9511CAearo Company · 2007 · cites it directly0descendants
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) | K070168 | N95 Respirator, Models N9504C, N9504CS and N9514C | Aearo Company | 2007 | — |
| +1 | K072359 | Aearo Company Surgical N95 Respirators, Models N9508C and N9511C | Aearo Company | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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…page 5. Copies of the 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. Aearo Company 510(k) 1/12/07 Page 4… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072359 | Aearo Company Surgical N95 Respirators, Models N9508C and N9511C | 2007 | 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 15 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072359 (Aearo Company, 2007) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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?
Aearo Surgical N95 Respirators, N9504C, N9504CS and N9514 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/K070168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070168: N95 Respirator, Models N9504C, N9504CS and N9514C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070168
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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