# K053240: Devilbiss Oxygen Cylinder Filling System, 535 Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Feb 3, 2006 after 77 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: 2 generations back to K971889 (1997). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013472: Total O2, Chad Therapeutics, Inc. (2001) Summary page 1.
- K971889: Chad Total O2 Delivery System, Chad Therapeutics, Inc. (1997) Summary page 1.

## Most influential descendants
- K091191: Gas Transfill (2009), 1 descendant of its own
- K141967: Purefill Oxygen Compressor (2014), 0 descendants of its own

## Recalls of this device
- Aug 24, 2006 · Not classified · Z-0038-2007: Potential for oxygen cylinders to not fill completely

## Indications for use
The Model 535D Oxygen Cylinder Filling System is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. The device is intended to provide 93% (± 3%) oxygen. This device can be used in homes, nursing homes, patient care facilities, etc.

Source page: https://510kreport.com/device/K053240
Methodology: https://510kreport.com/methodology