# K961626: Solo Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 18, 1996 after 83 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: 1 generation back to K952292 (1995). 2 ancestors in all.
114 later devices descend from it; 2 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953341: Aria Cpap System, Respironics, Inc. (1996) Summary page 1.
- K952292: Puritan-Bennett Companion Nasal Cpap System, Puritan Bennett Corp. (1995) Summary page 1.

## Most influential descendants
- K973161: Cpap Humidifier (HC 200) (1998), 110 descendants of its own
- K040941: Cpap Humidifier, Model HC234 (and Related Accessories) (2004), 98 descendants of its own
- K041900: HC604 Cpap Humidifier (2004), 74 descendants of its own
- K082605: Vpap Auto with Humidaire 3I (2009), 33 descendants of its own
- K091947: S8 Aspen with H4I Plus (2009), 31 descendants of its own

## Indications for use
The Respironics Solo CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA) only. The Solo CPAP System may be used in clinical settings (hospitals & sleep labs) and in home environments, and must be prescribed by a physician. It is not intended for life support or life sustaining applications. The device is used in conjunction with a mask (various styles and sizes available), headgear, and a combination of breathing circuit accessories.

Source page: https://510kreport.com/device/K961626
Methodology: https://510kreport.com/methodology