Cleared Traditional

STIMUPLEX HNS-11 (K003983) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003983 · Stockert GmbH · Anesthesiology device
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Jun 2001
Decision
162d
Days
Class 2
Risk

K003983 is an FDA 510(k) clearance for the STIMUPLEX HNS-11. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Stockert GmbH (Freiburg, DE). The FDA issued a Cleared decision on June 6, 2001 after a review of 162 days - an extended review 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: 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 Stockert GmbH devices

Submission Details

510(k) Number K003983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date June 06, 2001
Days to Decision 162 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
22d slower than avg
Panel avg: 140d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K003983.
STIMPOD NMS450 Nerve Stimulator
K213049 · Xavant Technology (Pty), Ltd. · Oct 2022
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033 · B.Braun Medical, Inc. · Mar 2003
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525 · Sherwood Medical Co. · Jan 1996
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
K862149 · Puritan Bennett Corp. · Jun 1986
BARD BIOMEDICAL NERVE LOCATOR
K791442 · C.R. Bard, Inc. · Sep 1979
NERVE STIMULATOR, DIGITAL PERIPHERAL
K791047 · C.R. Bard, Inc. · Jun 1979