# K191614: BioSticker System

- Pathway: 510(k) (Traditional)
- Applicant: Biointellisense, Inc.
- Decided: Dec 18, 2019 after 183 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K212957: BioButton System (2022), 1 descendant of its own
- K241101: BioButton System (2024), 0 descendants of its own

## Indications for use
The BioSticker System is a remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted via wireless connection from the BioSticker for storage and analysis. The device is intended for use on general care patients who are 21 years of age or older as a general patient monitor, to provide physiological information. The data from the BioSticker System are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended to measure physiological parameters while the patient undergoes significant motion or is active. The device is not intended for use on critical care patients.

Source page: https://510kreport.com/device/K191614
Methodology: https://510kreport.com/methodology