# K150494: Proteus Digital Health Feedback Device

- Pathway: 510(k) (Traditional)
- Applicant: Proteus Digital Health, Inc.
- Decided: Jun 27, 2015 after 122 days
- Product code: OZW (Ingestible Event Marker)
- Device class: 2
- Regulation: 21 CFR 880.6305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963725 (1997). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory), Proteus Digital Health, Inc. (2014) Summary page 4.

## Most influential descendants
- K223463: Otsuka Digital Feedback Device-RW (2023), 1 descendant of its own
- K251088: Otsuka Digital Feedback Device (2025), 0 descendants of its own
- K183052: ID-Cap System (2019), 0 descendants of its own

## Indications for use
The Proteus® Digital Health Feedback Device consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Proteus Digital Health Feedback Device is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Proteus Digital Health Feedback Device may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications.

Source page: https://510kreport.com/device/K150494
Methodology: https://510kreport.com/methodology