Cleared Traditional

K240763 - FirstFit Surgical Kit

K240763 is an FDA 510(k) clearance for FirstFit Surgical Kit, manufactured by Freudenberg Medical, LLC. The device is a Class 2 Ear, Nose, Throat device with product code EWL cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K240763 · Freudenberg Medical, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
273d
Days
Class 2
Risk

K240763 is an FDA 510(k) clearance for the FirstFit Surgical Kit. Classified as Prosthesis, Laryngeal (taub) (product code EWL), Class II - Special Controls.

Submitted by Freudenberg Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on December 18, 2024 after a review of 273 days - an extended review cycle.

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. 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 Freudenberg Medical, LLC devices

FDA 510(k) Submission Details - K240763

510(k) Number K240763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2024
Decision Date December 18, 2024
Days to Decision 273 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
184d slower than avg
Panel avg: 89d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

O'Connell & Myers, LLC
Trey Thorsen

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.

Regulatory Peers - EWL Prosthesis, Laryngeal (taub)

All 15
Devices cleared under the same product code (EWL) and FDA review panel - the closest regulatory comparables to K240763.
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486 · Exmoor Plastics , Ltd. · Sep 1992
BIVONA-COLORADO VOICE PROSTHESIS
K915761 · Bivona Medical Technologies · Jun 1992
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
K881011 · Bivona Medical Technologies · May 1988
ESKA-HERRMANN TRACHEOSTOMY VALVE
K871885 · C.R. Bard, Inc. · Jun 1987
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
K861088 · Bivona Medical Technologies · Apr 1986
BLOM-SINGER LOW PRESSURE VOICE PROSTHES
K842896 · American V. Mueller · Aug 1984