Cleared Traditional

K162086 - MultiStim ECO

K162086 is an FDA 510(k) clearance for MultiStim ECO, manufactured by PAJUNK GmbH Medizintechnologie. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K162086 · PAJUNK GmbH Medizintechnologie · Anesthesiology device
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Jan 2017
Decision
163d
Days
Class 2
Risk

K162086 is an FDA 510(k) clearance for the MultiStim ECO. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on January 6, 2017 after a review of 163 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. 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all PAJUNK GmbH Medizintechnologie devices

FDA 510(k) Submission Details - K162086

510(k) Number K162086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2016
Decision Date January 06, 2017
Days to Decision 163 days
Submission Type Traditional
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
23d slower than avg
Panel avg: 140d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 25
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K162086.
STIMPOD NMS450 Nerve Stimulator
K213049 · Xavant Technology (Pty), Ltd. · Oct 2022
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K153045 · Easy Med Instrument Co., Ltd. · May 2016
MiniStim MS-IVB Peripheral Nerve Stimulator
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