# K162515: COSMED K5 Wearable Metabolic Technology

- Pathway: 510(k) (Traditional)
- Applicant: Cosmed Srl
- Decided: Jun 20, 2017 after 285 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 K023120 (2003). 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)
- K023120: Oxycon Mobile, Erich Jaeger GmbH (2003) Summary page 6.

## Indications for use
The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use. The main measurements reported by the system are Oxygen Uptake, Carbon Dioxide production, Ventilation, Heart Rate and Energy Expenditure. K5 is intended to use with adults and children over the age of 14 years. It is to be used by physicians or by trained personnel on a physician responsibility. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient’s diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases

Source page: https://510kreport.com/device/K162515
Methodology: https://510kreport.com/methodology