Product Code: OZW FDA class 2 21 CFR 880.6305

Ingestible Event Marker

General Hospital

The Ingestible Event Marker is a general hospital device consisting of an ingestible component and a wearable component; when co-ingested with a medication, the ingestible component transmits a signal to the wearable component, which wirelessly communicates confirmation of the ingestion event and other information to a general computing device. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OZW, with regulation number 880.6305 under the General Hospital medical specialty, reviewed by the cardiovascular panel.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OZW
Device Class: FDA class 2
Regulation Number: 880.6305
Medical Specialty: General Hospital
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251088	Otsuka Digital Feedback Device	Jun 30, 2025	Substantially Equivalent	Otsuka America Pharmaceutical, Inc.
K223463	Otsuka Digital Feedback Device-RW	Aug 11, 2023	Substantially Equivalent	Otsuka America Pharmaceutical, Inc.
K183052	ID-Cap System	Dec 06, 2019	Substantially Equivalent	Etectrx, Inc.
K150494	Proteus Digital Health Feedback Device	Jun 27, 2015	Substantially Equivalent	Proteus Digital Health, Inc.
K133263	PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)	Feb 07, 2014	Substantially Equivalent	Proteus Digital Health, Inc.
K131524	PROTEUS PATCH INCLUDING INGESTIBLE SENSOR	Jun 23, 2013	Substantially Equivalent	Proteus Digital Health, Inc.
K131009	PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)	May 07, 2013	Substantially Equivalent	Proteus Digital Health, Inc.
DEN120011	PROTEUS INGESTION CONFINMATION SYSTEMS	Jul 10, 2012	Unknown	Proteus Biomedical, Inc.