# K192875: Philips Biosensor BX100

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Apr 16, 2020 after 191 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K123658 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181165: Philips wearable biosensor-G5 Solution, Connected Sensing- A Division of Philips Medical Systems (2019) Summary page 5.
- K123658: Biomodule 3-M1, Zephyr Technology Corporation (2013) Summary page 5.

## Indications for use
The Philips Biosensor BX100 is a physiological measurement device for use by healthcare professionals to aid in the treatment and management of patient conditions in general care areas of a hospital. The Philips Biosensor BX100 is intended for use by healthcare professionals on patients 18 years of age and older. This chest-worn biosensor collects, stores, and transmits physiological data and contextual parameters to a qualified backend system. Physiological data includes respiration rate and heart rate; contextual parameters include ambulation, activity level, and posture.

Source page: https://510kreport.com/device/K192875
Methodology: https://510kreport.com/methodology