# K963373: Cosmed K4

- Pathway: 510(k) (Traditional)
- Applicant: Cosmed Srl
- Decided: Sep 10, 1997 after 379 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945213 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945213: TEEN 100, Aerosport, Inc. (1995) Summary page 1.

## Indications for use
The Cosmed K4 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4 measures, in real conditions, the ventilation, the O₂ consumption the CO₂ production and the heart rate of the person being monitored.

Source page: https://510kreport.com/device/K963373
Methodology: https://510kreport.com/methodology