# K080391: Drive Solstice Oxygen Concentrator

- Pathway: 510(k) (Traditional)
- Applicant: Medical Depot
- Decided: Mar 18, 2008 after 34 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883591 (1988). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071608: A&J POCA01 Oxygen Concentrator, Zhongshan A&J Medical Equipment Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K090007: Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000 (2009), 4 descendants of its own
- K230969: Oxygen Concentrator (2023), 3 descendants of its own
- K252965: Oxygen Concentrator (OX-5A, OX-5C) (2026), 0 descendants of its own
- K253549: DeVilbiss 5 Liter Oxygen Concentrator (555) (2026), 0 descendants of its own
- K250805: DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (2025), 0 descendants of its own

## Recalls of this device
- Oct 9, 2017 · Class II · Z-0407-2018: Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below t

## Indications for use
The intended function and use of the Drive Solistice Oxygen Concentrator (models 18050 and 18055) is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

Source page: https://510kreport.com/device/K080391
Methodology: https://510kreport.com/methodology