# K212957: BioButton System

- Pathway: 510(k) (Traditional)
- Applicant: Biolntellisense, Inc.
- Decided: Dec 12, 2022 after 452 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K191614 (2019). 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)
- K191614: BioSticker System, Biointellisense, Inc. (2019) Summary page 5.

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

## Recalls of this device
- Jul 19, 2024 · Class II · Z-2616-2024: Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.

## Indications for use
The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection from the device for storage, review, and further analysis. The data from the device are intended as an aid to diagnosis, diseases management, and treatment. The device is intended for use on users who are 18 years of age or older. The device is not intended to output physiological measurements while the user undergoes significant motion or is active. The device is not intended for critical care.

Source page: https://510kreport.com/device/K212957
Methodology: https://510kreport.com/methodology