Cleared Traditional

K162086 - MultiStim ECO

K162086 is the FDA 510(k) clearance for MultiStim ECO by PAJUNK GmbH Medizintechnologie. It is a Class 2 Anesthesiology device (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

Submission Details

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.

Device Classification

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 14
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
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
K061172 · PAJUNK GmbH Medizintechnologie · Oct 2006
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · B.Braun Medical, Inc. · Mar 2003
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
MS-III MINISTIM
K913184 · Life-Tech Intl., Inc. · Oct 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · Utah Medical Products, Inc. · Jun 1991