Cleared Traditional

K093591 - STIMPOD MODEL NMS-400 NERVE STIMULATOR

K093591 is an FDA 510(k) clearance for STIMPOD MODEL NMS-400 NERVE STIMULATOR, manufactured by Xavant Technology (Pty), Ltd.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K093591 · Xavant Technology (Pty), Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
14d
Days
Class 2
Risk

K093591 is an FDA 510(k) clearance for the STIMPOD MODEL NMS-400 NERVE STIMULATOR. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Xavant Technology (Pty), Ltd. (Pretoria, Gauteng, ZA). The FDA issued a Cleared decision on December 3, 2009 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xavant Technology (Pty), Ltd. devices

FDA 510(k) Submission Details - K093591

510(k) Number K093591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2009
Decision Date December 03, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 32
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K093591.
MYOGUIDE SYSTEM MODEL 8008
K111985 · Intronix Technologies Corp. · Dec 2011
STIMTRODE SINGLE USE NERVE STIMULATOR
K110118 · Xavant Technology (Pty), Ltd. · Feb 2011
STIMPOD NMS450 NERVE STIMULATOR
K102084 · Xavant Technology (Pty), Ltd. · Dec 2010
ASCEND
K091155 · Neurometrix, Inc. · Sep 2009
XPOD/XMAP NERVE STIMULATOR
K072092 · Xavant Technology (Pty), Ltd. · Nov 2007
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
K070134 · Stockert GmbH · Mar 2007