Cleared Special

K112435 - RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

K112435 is an FDA 510(k) clearance for RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT, manufactured by Rhythmlink International, LLC. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Special 510(k) pathway after a 29-day FDA review.

K112435 · Rhythmlink International, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
29d
Days
Class 2
Risk

K112435 is an FDA 510(k) clearance for the RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on September 22, 2011 after a review of 29 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rhythmlink International, LLC devices

FDA 510(k) Submission Details - K112435

510(k) Number K112435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2011
Decision Date September 22, 2011
Days to Decision 29 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
61d faster than avg
Panel avg: 90d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 79
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K112435.
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · Seaspine, Inc. · Dec 2011
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K110989 · Neurovision Medical Products, Inc. · Nov 2011
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
NEURO CHECK DEVICE WITH IO-FLEX WIRE
K110696 · Baxano, Inc. · Jul 2011
DRYTOUCH SUCTION STIMULATOR PROBE
K110712 · Neurovision Medical Products, Inc. · Jun 2011
SURGICAL STIMULATORS
K110422 · Technomed Europe · May 2011