# K141967: Purefill Oxygen Compressor

- Pathway: 510(k) (Traditional)
- Applicant: Inovo, Inc.
- Decided: Nov 7, 2014 after 109 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: 4 generations back to K971889 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091191: Gas Transfill, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 4.
- K003939: Venture Home Fill II, Model Ioh 200, Invacare Corp. (2001) Summary page 4.

## Recalls of this device
- Jul 21, 2016 · Class II · Z-0760-2017: Device can fail during operation.

## Indications for use
The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining. Environment of use: - Sub-acute care facilities and home settings

Source page: https://510kreport.com/device/K141967
Methodology: https://510kreport.com/methodology