# K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory)

- Pathway: 510(k) (Special)
- Applicant: Proteus Digital Health, Inc.
- Decided: Feb 7, 2014 after 107 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: 6 generations back to K963725 (1997). 16 ancestors in all.
4 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)
- K131009: Proteus Patch, Ingestible Sensor (Accessory), Proteus Digital Health, Inc. (2013) Summary page 1.

## Most influential descendants
- K150494: Proteus Digital Health Feedback Device (2015), 3 descendants of its own
- 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® Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.

Source page: https://510kreport.com/device/K133263
Methodology: https://510kreport.com/methodology