# K041828: Apex Medical Cpap Model 9S-003

- Pathway: 510(k) (Special)
- Applicant: Apex Medical Corp.
- Decided: Jul 30, 2004 after 23 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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/K041828
Methodology: https://510kreport.com/methodology