# K152139: Vital Connect Platform, HealthPatch MD, VitalPatch

- Pathway: 510(k) (Traditional)
- Applicant: Vitalconnect, Inc.
- Decided: Dec 6, 2015 after 125 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: 8 generations back to K962603 (1997). 25 ancestors in all.
43 later devices descend from it; 9 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library), Vitalconnect, Inc. (2014) Summary page 4.

## Most influential descendants
- K163255: CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor (2017), 15 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K163453: VitalPatch® VitalConnect Platform (2017), 11 descendants of its own
- K172329: Patient Status Engine (2018), 10 descendants of its own
- K183078: VitalConnect Platform, VitalPatch Biosensor (2019), 9 descendants of its own

## Indications for use
The Vital Connect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the Vital Connect Sensor for storage and analysis. The Vital Connect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K152139
Methodology: https://510kreport.com/methodology