# K173510: BioStamp nPoint

- Pathway: 510(k) (Traditional)
- Applicant: Mc10, Inc.
- Decided: May 8, 2018 after 176 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: 9 generations back to K962603 (1997). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch, Vitalconnect, Inc. (2015) Summary page 4.
- K132764: Motion Watch and Pro-Diary, Camntech, Ltd. (2014) Summary page 4.
- K113074: Cmap Pro, Medical Technologies, Inc. (2012) Summary page 4.

## Indications for use
BioStamp nPoint is a wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and professional healthcare settings during research studies. These physiological data include heart rate, heart rate variability, respiration rate, activity (including step count and activity classification), and posture (body position relative to gravity). The system is also intended for measurement of surface electromyography, and to monitor limb or body movements during daily living and sleep. Data are transmitted wirelessly from the Sensors for storage and analysis. 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 BioStamp nPoint system are only intended for use by researchers and healthcare professionals for research applications, including at the discretion of a qualified healthcare professional as an aid to diagnosis and treatment in the context of clinical research and product development. The device is not intended for use on critical care patients, and is not a real time or remote diagnostic device.

Source page: https://510kreport.com/device/K173510
Methodology: https://510kreport.com/methodology