Cleared Traditional

K143095 - MiniStim MS-IVB Peripheral Nerve Stimulator

K143095 is an FDA 510(k) clearance for MiniStim MS-IVB Peripheral Nerve Stimulator, manufactured by Halyard Health, Inc.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K143095 · Halyard Health, Inc. · Anesthesiology device
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Mar 2015
Decision
147d
Days
Class 2
Risk

K143095 is an FDA 510(k) clearance for the MiniStim MS-IVB Peripheral Nerve Stimulator. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Halyard Health, Inc. (Roswell, US). The FDA issued a Cleared decision on March 24, 2015 after a review of 147 days - within the typical 510(k) review window.

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 Halyard Health, Inc. devices

FDA 510(k) Submission Details - K143095

510(k) Number K143095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2014
Decision Date March 24, 2015
Days to Decision 147 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 140d · This submission: 147d
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 15
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K143095.
STIMPOD NMS450 Nerve Stimulator
K213049 · Xavant Technology (Pty), Ltd. · Oct 2022
MultiStim ECO
K162086 · PAJUNK GmbH Medizintechnologie · Jan 2017
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