# K061870: Vitalsense XHR

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Aug 31, 2006 after 59 days
- Product code: GWK (Conditioner, Signal, Physiological)
- Device class: 2
- Regulation: 21 CFR 882.1845
- 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 K914085 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033534: Vitalsense, Mini-Mitter Co., Inc. (2004) Summary page 1.
- K052489: Actiheart, Respironics, Inc. (2005) Summary page 1.

## Indications for use
The VitalSense XHR can be used in any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable.

Source page: https://510kreport.com/device/K061870
Methodology: https://510kreport.com/methodology