Cleared Traditional

K092292 - CHECKPOINT

K092292 is an FDA 510(k) clearance for CHECKPOINT, 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 91-day FDA review.

K092292 · Ndi Medical, LLC · Ear, Nose, Throat device
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Oct 2009
Decision
91d
Days
Class 2
Risk

K092292 is an FDA 510(k) clearance for the CHECKPOINT. 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 October 28, 2009 after a review of 91 days - within the typical 510(k) review window.

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: 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 Ndi Medical, LLC devices

FDA 510(k) Submission Details - K092292

510(k) Number K092292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date October 28, 2009
Days to Decision 91 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
2d slower than avg
Panel avg: 89d · This submission: 91d
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 K092292.
STIMULATION/DISSECTION INSTRUMENTS
K112709 · Nu Vasive, Incorporated · Feb 2012
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · Seaspine, Inc. · Dec 2011
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