# K140929: Z1 Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Human Design Medical, LLC
- Decided: Oct 17, 2014 after 191 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 K903764 (1990). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121374: ZI Blower, Deshum Medical (2013) Summary page 4.
- K063476: Breas Isleep 20I, Breas Medical AB (2007) Summary page 4.
- K100121: Model 300157 Cpap System, Aeiomed, Inc. (2010) Summary page 4.

## Indications for use
The Z1 CPAP System is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep apnea.

Source page: https://510kreport.com/device/K140929
Methodology: https://510kreport.com/methodology