# K071397: Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 Series

- Pathway: 510(k) (Special)
- Applicant: Sunrise Medical
- Decided: Oct 1, 2007 after 133 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K091541: Mesa Oxygen Concentrator, Model 2-6000 Series (2009), 0 descendants of its own

## Recalls of this device
- Apr 11, 2025 · Class I · Z-1727-2025: Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
- Mar 9, 2023 · Class II · Z-1558-2023: The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.
- Nov 18, 2022 · Class II · Z-0724-2023: The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 de

Source page: https://510kreport.com/device/K071397
Methodology: https://510kreport.com/methodology