# K982242: Invacare Cpap

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Jan 27, 1999 after 216 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: 2 generations back to K952292 (1995). 4 ancestors in all.
2 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)
- K930656: Sullivan Iii Nasal Cpap System, Rescare, Ltd. (1994) Summary page 1.
- K961626: Solo Cpap System, Respironics, Inc. (1996) Summary page 1.

## Most influential descendants
- K041823: Pioneer U121 Series Cpap (2005), 0 descendants of its own
- K031064: Invacare Polaris EX Cpap, Model ISP3000 (2004), 0 descendants of its own

## Indications for use
To treat Obstructive Sleep Apnea (OSA) in adults by delivering continuous positive airway pressure.

Source page: https://510kreport.com/device/K982242
Methodology: https://510kreport.com/methodology