# K041568: EOCD

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Jul 21, 2004 after 41 days
- Product code: NFB (Conserver, Oxygen)
- 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: 2 generations back to K961126 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020329: Devilbiss PD1000, Sunrise Medical Hhg, Inc. (2002) Summary page 1.

## Indications for use
The EOCD is intended as a pulse dose delivery device for medical-grade oxygen from portable high-pressure oxygen cylinders. Adult patients requiring supplemental oxygen and using ambulatory oxygen can use the EOCD to extend the use time of a fixed volume oxygen source. This device does not provide alarms and is not intended as life support.

Source page: https://510kreport.com/device/K041568
Methodology: https://510kreport.com/methodology
