# K200076: Breezing Med

- Pathway: 510(k) (Traditional)
- Applicant: Tf Health Co.
- Decided: Sep 25, 2020 after 255 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: 3 generations back to K955432 (1996). 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)
- K070858: Express Series, Medical Graphics Corp. (2007) Summary page 4.

## Indications for use
Breezing Med™ Metabolism Analyzer measures metabolic functions including resting energy expenditure and respiratory quotient during resting conditions via direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements, and to quantify substrate utilization. The nutritional assessment enables the healthcare professional to further assess energy expenditure and caloric intake for weight management, and to aid in the diagnosis of diseases related to abnormal metabolic parameters. Breezing Med is intended for use with adults breathing normally on their own in a sitting position in a healthcare environment. Since the device is designed for the patient to breathe ambient air, it is not intended for patients where supplementary oxygen is being provided. Breezing Med is not intended to use as sole means for any diagnosis, and ultimately will provide data for evaluation by the professional.

Source page: https://510kreport.com/device/K200076
Methodology: https://510kreport.com/methodology