Cleared Abbreviated

K052313 - STIMUPLEX HNS-12, MODEL 4892098

K052313 is an FDA 510(k) clearance for STIMUPLEX HNS-12, manufactured by Stockert GmbH. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Abbreviated 510(k) pathway after a 84-day FDA review.

K052313 · Stockert GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
84d
Days
Class 2
Risk

K052313 is an FDA 510(k) clearance for the 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 November 17, 2005 after a review of 84 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K052313

510(k) Number K052313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2005
Decision Date November 17, 2005
Days to Decision 84 days
Submission Type Abbreviated
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
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Standards-based clearance path.

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 K052313.
CLAVIS
K062478 · Medtronic A/S · Feb 2007
STIMUPLEX PEN
K061983 · Stockert GmbH · Nov 2006
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
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STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · B.Braun Medical, Inc. · Mar 2003
MULTISTIM
K011308 · Pajunk GmbH · Nov 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323 · Te ME NA S.A.R.L. · Sep 2001