Cleared Special

K153045 - SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

K153045 is an FDA 510(k) clearance for SunStim Peripheral Nerve Stimulator/Sun..., manufactured by Easy Med Instrument Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Special 510(k) pathway after a 207-day FDA review.

K153045 · Easy Med Instrument Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
207d
Days
Class 2
Risk

K153045 is an FDA 510(k) clearance for the SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Easy Med Instrument Co., Ltd. (Daliang, Shunde, Foshan, CN). The FDA issued a Cleared decision on May 13, 2016 after a review of 207 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K153045

510(k) Number K153045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2015
Decision Date May 13, 2016
Days to Decision 207 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 140d · This submission: 207d
Pathway characteristics
Modification to existing cleared device.

BXN Device Classification - Class 2, Special Controls

Product Code BXN Stimulator, Nerve, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BXN Stimulator, Nerve, Battery-powered

All 33
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K153045.
STIMPOD NMS450 Nerve Stimulator
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K143095 · Halyard Health, Inc. · Mar 2015
STIMPOD ST2-3010 NERVE STIMULATOR
K140853 · Xavant Technology (Pty), Ltd. · Nov 2014
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K121743 · Sunmed, LLC · Mar 2013
MYOGUIDE SYSTEM MODEL 8008
K111985 · Intronix Technologies Corp. · Dec 2011