# K131524: Proteus Patch Including Ingestible Sensor

- Pathway: 510(k) (Special)
- Applicant: Proteus Digital Health, Inc.
- Decided: Jun 23, 2013 after 26 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.
No later device cites it as a predicate yet.
0 of 17 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.

## 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 relatve 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/K131524
Methodology: https://510kreport.com/methodology