Cleared Traditional

K061365 - CHECKPOINT WITH ACCUSTIM TECHNOLOGY

K061365 is an FDA 510(k) clearance for CHECKPOINT WITH ACCUSTIM TECHNOLOGY, manufactured by Ndi Medical, LLC. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K061365 · Ndi Medical, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
57d
Days
Class 2
Risk

K061365 is an FDA 510(k) clearance for the CHECKPOINT WITH ACCUSTIM TECHNOLOGY. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Ndi Medical, LLC (Cleveland, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ndi Medical, LLC devices

FDA 510(k) Submission Details - K061365

510(k) Number K061365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2006
Decision Date July 12, 2006
Days to Decision 57 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
32d faster than avg
Panel avg: 89d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 - ETN Stimulator, Nerve

All 42
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K061365.
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
STIMULATING BUR GUARD
K063305 · Medtronic Xomed, Inc. · Nov 2006
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K062549 · Excel Tech. , Ltd. · Oct 2006
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · Medtronic Xomed, Inc. · Mar 2005
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc. · Apr 2004