Cleared Traditional

CLEAR™ Aspiration System (K253404) - FDA 510(k) Clearance

K253404 · Insera Therapeutics, Inc. · Cardiovascular device
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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

Submission Details

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

Product Code -
Device Class -