# K010577: Bodygem, Model HB211

- Pathway: 510(k) (Traditional)
- Applicant: Healthetech, Inc.
- Decided: Jan 10, 2002 after 317 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021490: Reevue Indirect Calorimeter, Model#8100 (2003), 2 descendants of its own
- K190561: NICU V'02 (2020), 0 descendants of its own
- K071533: Fitmate Series (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K010577
Methodology: https://510kreport.com/methodology