Cleared Traditional

C2 Xplore (K223254) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223254 · Inomed Medizintechnik GmbH · Ear, Nose, Throat device
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Jan 2023
Decision
98d
Days
Class 2
Risk

K223254 is an FDA 510(k) clearance for the C2 Xplore. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on January 27, 2023 after a review of 98 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 Inomed Medizintechnik GmbH devices

Submission Details

510(k) Number K223254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2022
Decision Date January 27, 2023
Days to Decision 98 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
9d slower than avg
Panel avg: 89d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K223254.
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · Medtronic Xomed, Inc. · Oct 2023
EARP Nerve Cuff Electrode
K230853 · Nvision Biomedical Technologies, Inc. · Oct 2023
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580 · Medtronic Xomed, Inc. · Aug 2023
Mapping Suction Probe
K212164 · Inomed Medizintechnik GmbH · Nov 2022
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
K213246 · Medtronic Xomed, Inc. · Mar 2022
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
K212355 · Checkpoint Surgical · Aug 2021