# K120035: Apex Medical Ich Cpap Series (9S-007XXX)

- Pathway: 510(k) (Special)
- Applicant: Apex Medical Corp.
- Decided: May 16, 2012 after 133 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 K971260 (1997). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083656: Apex Medical XT Auto Cpap 9S-005200, Apex Medical Corp. (2009) Summary page 1.
- K062664: Humidcare Heated Humidifier, Model 9S-004, Apex Medical Corp. (2006) Summary page 1.

## Most influential descendants
- K141522: Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series (2014), 1 descendant of its own
- K150111: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (2015), 0 descendants of its own

## Indications for use
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).

Source page: https://510kreport.com/device/K120035
Methodology: https://510kreport.com/methodology