Cleared Traditional

K131745 - BLOM-SINGER SEPTAL PERFORATION PROSTHESIS (FDA 510(k) Clearance)

K131745 · Helix Medical, LLC · Ear, Nose, Throat device
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Sep 2013
Decision
96d
Days
-
Risk

K131745 is an FDA 510(k) clearance for the BLOM-SINGER SEPTAL PERFORATION PROSTHESIS. Classified as Button, Nasal Septal (product code LFB).

Submitted by Helix Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on September 17, 2013 after a review of 96 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.

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Submission Details

510(k) Number K131745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2013
Decision Date September 17, 2013
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 89d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -