# K071533: Fitmate Series

- Pathway: 510(k) (Traditional)
- Applicant: Cosmed Srl
- Decided: Sep 28, 2007 after 115 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
Longest line of descent: 2 generations back to K010577 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021490: Reevue Indirect Calorimeter, Model#8100, Korr Medical Technologies, Inc. (2003) Summary page 2.
- K001174: Cosmed Quark, Cosmed Srl (2001) Summary page 2.

## Indications for use
This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

Source page: https://510kreport.com/device/K071533
Methodology: https://510kreport.com/methodology