# K183052: ID-Cap System

- Pathway: 510(k) (Traditional)
- Applicant: Etectrx, Inc.
- Decided: Dec 6, 2019 after 399 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: 8 generations back to K963725 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150494: Proteus Digital Health Feedback Device, Proteus Digital Health, Inc. (2015) Summary page 4.

## Indications for use
The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.

Source page: https://510kreport.com/device/K183052
Methodology: https://510kreport.com/methodology