# K070609: Apex Medical XT1 Cpap, Model 9S-005

- Pathway: 510(k) (Special)
- Applicant: Apex Medical Corp.
- Decided: May 4, 2007 after 60 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083656: Apex Medical XT Auto Cpap 9S-005200 (2009), 4 descendants of its own
- K112079: Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 (2012), 2 descendants of its own
- K120035: Apex Medical Ich Cpap Series (9S-007XXX) (2012), 2 descendants of its own
- 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/K070609
Methodology: https://510kreport.com/methodology