510(k) · Cleared

Cleared

Isolair Apr Type N95

K960778510(k) TraditionalCleared May 9, 199673-day reviewClass II21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Louis M. Gerson Co., Inc. · MSH Respirator, Surgical

Cleared on May 9, 1996 as substantially equivalent to K922507 (Louis M. Gerson Co., Inc., 1992) after a 73-day review. Its family tree reaches back 1 generation to 1992. 21 later devices descend from it.

Decided: May 9, 1996
Review: 73 days
Class: Class II
Product code: MSH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922507 (1992). 21 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
This deviceK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
Descendant · cites it directly · 15 of its ownK041855 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 · 2 generations on · 5 of its ownK070139 Willson One-Fit Healthcare Particle Respirator and Surgical Mask…Survivair, Inc. · 2007
Descendant · 3 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

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1997high 5 (2007) · low 0 (1998)2026

Most influential descendants

Showing 5 of 21 · See all

K041855Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004 · cites it directly15descendants
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 · 2 generations on5descendants
K070782Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models…Survivair Respirators, LLC · 2007 · 3 generations on3descendants
K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 2006 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922507	Gerson Isolair Apr Particulate Surgical Mask	Louis M. Gerson Co., Inc.	1992	—
0 (this device)	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	—
+1	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	—
+3	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	1	0
2004	1	0
2005	1	0
2006	3	0
2007	5	0
2008	2	0
2009	2	0
2010	4	0
2015	1	0

FIG. 1 — Lineage of K960778, 1992–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K922507	Gerson Isolair Apr Particulate Surgical Mask Summary page 1 …son Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is found to be substantially equivalent to the Gerson Isolair SMF 510 (k) number K922507. The product is manufactured in the same manner but utilizes more efficient filter media. o 3l o0 iyl [ ] FRI…	Louis M. Gerson Co., Inc.	1992	—

What descends from it? (21)

See all 21

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041855	Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S	Aearo Co.	2004	15
K051182	Inovel Health Care Model N95 Particulate Respirators and Surgical Masks	Inovel, LLC	2005	11
K070168	N95 Respirator, Models N9504C, N9504CS and N9514C	Aearo Company	2007	1
K102923	Barrier N95 Particulate Respirator	Molnlycke Health Care	2010	0
K090131	DS N95 Surgical Masks and Flat Surgical	Shanghai Dasheng Health Products	2009	0
K080827	Handan N95 Particulate Respirators and Surgical Mask, Models HY8510 and HY9810	Handan Hengyong Protective & Clean Products Co., L	2008	0
K020474	Makrite Type N95 Respirator and Surgical Mask Model 910-N95	Makrite Industries, Inc.	2002	0
K964723	Racal N95 Resirator	Racal Filter Technologies, Inc.	1997	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?

Its one ancestor has no recall.
Of its descendants, K041855 (Aearo Co., 2004) has gone furthest, with 15 descendants of its own.

How does its category compare?

All MSH devices

MSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSH

1in 2024

2007high 7 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSH

60in 2010

2007high 78 (2007) · low 60 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MSH

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MSH

10in 2025

2007high 71 (2023) · low 0 (2007)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 Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

This device also meets CDC Guidelines for "B Exposure Control.

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/K960778 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960778: Isolair Apr Type N95.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960778

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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