Cleared Traditional

K251088 - Otsuka Digital Feedback Device (FDA 510(k) Clearance)

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

K251088 · Otsuka America Pharmaceutical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
82d
Days
Class 2
Risk

K251088 is an FDA 510(k) clearance for the Otsuka Digital Feedback Device. Classified as Ingestible Event Marker (product code OZW), Class II - Special Controls.

Submitted by Otsuka America Pharmaceutical, Inc. (Hayward, US). The FDA issued a Cleared decision on June 30, 2025 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Otsuka America Pharmaceutical, Inc. devices

Submission Details

510(k) Number K251088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2025
Decision Date June 30, 2025
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
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.

Regulatory Consultant

Otsuka Product Development & Commercialization, Inc.
Nancy Teague

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.