# K021605: Medgem

- Pathway: 510(k) (Special)
- Applicant: Healthetech, Inc.
- Decided: Jun 14, 2002 after 29 days
- Product code: BZL (Computer, Oxygen-Uptake)
- Device class: 2
- Regulation: 21 CFR 868.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

Source page: https://510kreport.com/device/K021605
Methodology: https://510kreport.com/methodology