DeviceClearance

Product code OZW— General Hospital

ID-Cap System

Classification name
Ingestible Event Marker
Device class
Class 2
Regulation
21 CFR 880.6305
Advisory panel
General Hospital
Total cleared
8
First cleared
Most recent

FDA classification definition

“To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device”

— U.S. Food and Drug Administration, device classification record for product code OZW under 21 CFR 880.6305, via openFDA

Market context for product code OZW

FDA has cleared 8 devices under product code OZW between 2012 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OZW

Recent clearances under product code OZW

Data sourced from openFDA. This site is unofficial and independent of the FDA.