# K131009: Proteus Patch, Ingestible Sensor (Accessory)

- Pathway: 510(k) (Special)
- Applicant: Proteus Digital Health, Inc.
- Decided: May 7, 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: 5 generations back to K963725 (1997). 15 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120011: Proteus Ingestion Confinmation Systems, Proteus Biomedical, Inc. (2012). Our reading of the summary gave K113070, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120011, Proteus Ingestion Confinmation Systems (Proteus Biomedical, Inc.), granted Jul 10, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K093976: Raisin Personal  Monitor, Proteus Biomedical, Inc. (2010) Summary page 1.

## Most influential descendants
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory) (2014), 4 descendants of its own
- 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, also called the 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 heart rate, activity, and body position is desirable.

Source page: https://510kreport.com/device/K131009
Methodology: https://510kreport.com/methodology