Cleared Traditional

K991899 - NIHON KOHDEN MEB-2200A NEUROPACK EVOKED...

K991899 is an FDA 510(k) clearance for NIHON KOHDEN MEB-2200A NEUROPACK EVOKED..., manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K991899 · Nihon Kohden America, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
89d
Days
Class 2
Risk

K991899 is an FDA 510(k) clearance for the NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH.... Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K991899

510(k) Number K991899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1999
Decision Date September 01, 1999
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 Neurology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 60
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K991899.
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
K010087 · Excel Tech. , Ltd. · Mar 2001
NEUROMAP WITH NEURO 100
K002773 · Radionics, Inc. · Oct 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
K001101 · Excel Tech. , Ltd. · Jun 2000
XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
K992313 · Excel Tech. , Ltd. · Aug 1999
GALILEO EVOKED POTENTIALRE
K963662 · Biosound, Inc. · Feb 1997
FOUR-CHANNEL PREAMPLIFIER
K962455 · Cadwell Laboratories, Inc. · Jan 1997