# K200401: Apogee

- Pathway: 510(k) (Traditional)
- Applicant: Incoba Ltd D/B/A Dynaris
- Decided: Nov 14, 2020 after 270 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: 5 generations back to K933930 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090421: Model 350G Gas Conserver, Inspired Technologies, Inc. (2009) Summary page 4.

## Indications for use
The Apogee is a gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders. Apogee is an ambulatory device which allows patients to ambulate longer than they would with continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.

Source page: https://510kreport.com/device/K200401
Methodology: https://510kreport.com/methodology