# K972605: Ems Nasal Cpap Mask

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Jan 28, 1998 after 201 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: 1 generation back to K883825 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883825: Modified Sanders BI-Papeasy, Respironics, Inc. (1988) Summary page 1.

## Indications for use
The EMS Nasal CPAP mask and accessories (mask, spacers, mask support ring and headgear) are used with and attached to a positive pressure air source, CPAP or Bi-level equipment, and has the Indications for Use consistent with the Indications for Use of the equipment to which it is attached.

Source page: https://510kreport.com/device/K972605
Methodology: https://510kreport.com/methodology