# K150111: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Sep 15, 2015 after 238 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: 9 generations back to K971260 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141522: Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series, Apex Medical Corp. (2014) Summary page 4.

## Indications for use
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.

Source page: https://510kreport.com/device/K150111
Methodology: https://510kreport.com/methodology