Cleared Special

K093258 - BLOM-SINGER INDWELLING TEP OCCLUDER

K093258 is an FDA 510(k) clearance for BLOM-SINGER INDWELLING TEP OCCLUDER, manufactured by Helix Medical, LLC. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Special 510(k) pathway after a 135-day FDA review.

K093258 · Helix Medical, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Mar 2010
Decision
135d
Days
Class 2
Risk

K093258 is an FDA 510(k) clearance for the BLOM-SINGER INDWELLING TEP OCCLUDER. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Helix Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on March 3, 2010 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3730 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Helix Medical, LLC devices

FDA 510(k) Submission Details - K093258

510(k) Number K093258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2009
Decision Date March 03, 2010
Days to Decision 135 days
Submission Type Special
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
45d slower than avg
Panel avg: 90d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

EWL Device Classification - Class 2, Special Controls

Product Code EWL Prosthesis, Laryngeal (taub)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3730
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWL Prosthesis, Laryngeal (taub)

All 29
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K093258.
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