# K123897: K Series Cpap Systems

- Pathway: 510(k) (Special)
- Applicant: Curative Medical, Inc.
- Decided: Mar 13, 2013 after 85 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: 7 generations back to K953930 (1996). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120285: K Series Cpap System with Heated Humidifer, Curative Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K130828: K Series Cpap Systems (2014), 0 descendants of its own
- K131702: K Series Cpap Systems (2013), 0 descendants of its own

## 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 hospltailinstitutlonal environment.

Source page: https://510kreport.com/device/K123897
Methodology: https://510kreport.com/methodology