Cleared Traditional

K261725 - OtoCompanion (Version 1.0)

K261725 · Ironsides Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
118d
Days
-
Risk

K261725 is an FDA 510(k) clearance for the OtoCompanion (Version 1.0).

Submitted by Ironsides Medical, Inc. (Cambridge, US). The FDA issued a Cleared decision on September 21, 2026 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Ironsides Medical, Inc. devices

FDA 510(k) Submission Details - K261725

510(k) Number K261725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2026
Decision Date September 21, 2026
Days to Decision 118 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 90d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

SHL Device Classification - Class ,

Product Code SHL
Device Class -

Regulatory Consultant

DuVal & Associates
Allison Komiyama

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.