# K131702: K Series Cpap Systems

- Pathway: 510(k) (Traditional)
- Applicant: Curative Medical, Inc.
- Decided: Dec 6, 2013 after 178 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: 8 generations back to K953930 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123897: K Series Cpap Systems, Curative Medical, Inc. (2013) Summary page 1.

## Indications for use
The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K131702
Methodology: https://510kreport.com/methodology