# K960778: Isolair Apr Type N95

- Pathway: 510(k) (Traditional)
- Applicant: Louis M. Gerson Co., Inc.
- Decided: May 9, 1996 after 73 days
- Product code: MSH (Respirator, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922507 (1992). 1 ancestor in all.
21 later devices descend from it; 8 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922507: Gerson Isolair Apr Particulate Surgical Mask, Louis M. Gerson Co., Inc. (1992) Summary page 1.

## Most influential descendants
- K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S (2004), 15 descendants of its own
- K051182: Inovel Health Care Model N95 Particulate Respirators and Surgical Masks (2005), 11 descendants of its own
- K070139: Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 (2007), 5 descendants of its own
- K070782: Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models HC-NB095F and HC-NB295F (2007), 3 descendants of its own
- K061859: Inovel Health Care N95 Particulate Respirators & Surgical Masks (2006), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K960778
Methodology: https://510kreport.com/methodology