Cleared Traditional

K223463 - Otsuka Digital Feedback Device-RW (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223463 · Otsuka America Pharmaceutical, Inc. · Cardiovascular device
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Aug 2023
Decision
268d
Days
Class 2
Risk

K223463 is an FDA 510(k) clearance for the Otsuka Digital Feedback Device-RW. Classified as Ingestible Event Marker (product code OZW), Class II - Special Controls.

Submitted by Otsuka America Pharmaceutical, Inc. (Rockville, US). The FDA issued a Cleared decision on August 11, 2023 after a review of 268 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.6305 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Otsuka America Pharmaceutical, Inc. devices

Submission Details

510(k) Number K223463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2022
Decision Date August 11, 2023
Days to Decision 268 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 125d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZW Ingestible Event Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6305
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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.