# K072755: Galemed Cpap Mask

- Pathway: 510(k) (Traditional)
- Applicant: Galemed Corp.
- Decided: Nov 16, 2007 after 50 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833786 (1983). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235, Hsiner Co., Ltd. (2007) Summary page 1.

## Indications for use
The GaleMed CPAP masks are intended to be used in a home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.

Source page: https://510kreport.com/device/K072755
Methodology: https://510kreport.com/methodology