# K922507: Gerson Isolair Apr Particulate Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Louis M. Gerson Co., Inc.
- Decided: Nov 16, 1992 after 173 days
- Product code: FXX (Mask, 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
No predicates in its family tree.
22 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960778: Isolair Apr Type N95 (1996), 21 descendants of its own
- 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

Source page: https://510kreport.com/device/K922507
Methodology: https://510kreport.com/methodology