Cleared Special

K070134 - MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098

K070134 is an FDA 510(k) clearance for MODIFICATION TO STIMUPLEX HNS-12, manufactured by Stockert GmbH. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Special 510(k) pathway after a 65-day FDA review.

K070134 · Stockert GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
65d
Days
Class 2
Risk

K070134 is an FDA 510(k) clearance for the MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Stockert GmbH (Freiburg, B-W, DE). The FDA issued a Cleared decision on March 22, 2007 after a review of 65 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070134

510(k) Number K070134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2007
Decision Date March 22, 2007
Days to Decision 65 days
Submission Type Special
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
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

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 K070134.
STIMPOD MODEL NMS-400 NERVE STIMULATOR
K093591 · Xavant Technology (Pty), Ltd. · Dec 2009
ASCEND
K091155 · Neurometrix, Inc. · Sep 2009
XPOD/XMAP NERVE STIMULATOR
K072092 · Xavant Technology (Pty), Ltd. · Nov 2007
CLAVIS
K062478 · Medtronic A/S · Feb 2007
STIMUPLEX PEN
K061983 · Stockert GmbH · Nov 2006
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
K061172 · PAJUNK GmbH Medizintechnologie · Oct 2006