Cleared Traditional

K253404 - CLEAR Aspiration System

K253404 · Insera Therapeutics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2026
Decision
267d
Days
-
Risk

K253404 is an FDA 510(k) clearance for the CLEAR™ Aspiration System.

Submitted by Insera Therapeutics, Inc. (Dallas, US). The FDA issued a Cleared decision on June 24, 2026 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Insera Therapeutics, Inc. devices

FDA 510(k) Submission Details - K253404

510(k) Number K253404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date June 24, 2026
Days to Decision 267 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -