# K181165: Philips wearable biosensor-G5 Solution

- Pathway: 510(k) (Traditional)
- Applicant: Connected Sensing- A Division of Philips Medical Systems
- Decided: Mar 7, 2019 after 309 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K123658 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123658: Biomodule 3-M1, Zephyr Technology Corporation (2013) Summary page 4.

## Most influential descendants
- K192875: Philips Biosensor BX100 (2020), 0 descendants of its own

## Indications for use
The Philips wearable biosensor-G5 is indicated for single patient use whenever heart rate measurement is needed in non-critical hospital settings. The Philips wearable biosensor-G5 solution is used as a higher resolution heart rate log by nurses or physicians retrospectively as an aid in making non-critical or non-life threatening therapeutic decisions. The biosensor is intended for patients who are 18 years of age or older. The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).

Source page: https://510kreport.com/device/K181165
Methodology: https://510kreport.com/methodology