Cleared Traditional

K213049 - STIMPOD NMS450 Nerve Stimulator

K213049 is an FDA 510(k) clearance for STIMPOD NMS450 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 389-day FDA review.

K213049 · Xavant Technology (Pty), Ltd. · Anesthesiology device
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Oct 2022
Decision
389d
Days
Class 2
Risk

K213049 is an FDA 510(k) clearance for the STIMPOD NMS450 Nerve Stimulator. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Xavant Technology (Pty), Ltd. (Pretoria, ZA). The FDA issued a Cleared decision on October 16, 2022 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Xavant Technology (Pty), Ltd. devices

FDA 510(k) Submission Details - K213049

510(k) Number K213049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2021
Decision Date October 16, 2022
Days to Decision 389 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
249d slower than avg
Panel avg: 140d · This submission: 389d
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 14
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K213049.
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
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · Utah Medical Products, Inc. · Jun 1991