# K041823: Pioneer U121 Series Cpap

- Pathway: 510(k) (Traditional)
- Applicant: Merits Health Products Co., Ltd.
- Decided: May 10, 2005 after 308 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: 3 generations back to K952292 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982242: Invacare Cpap, Invacare Corp. (1999) Summary page 1.

## Indications for use
The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K041823
Methodology: https://510kreport.com/methodology