Cleared Traditional

K972959 - AMPLAID MK22

K972959 is an FDA 510(k) clearance for AMPLAID MK22, manufactured by Amplifon S.P.A.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K972959 · Amplifon S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
179d
Days
Class 2
Risk

K972959 is an FDA 510(k) clearance for the AMPLAID MK22. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Amplifon S.P.A. (Deer Field, US). The FDA issued a Cleared decision on February 6, 1998 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amplifon S.P.A. devices

FDA 510(k) Submission Details - K972959

510(k) Number K972959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date February 06, 1998
Days to Decision 179 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
31d slower than avg
Panel avg: 148d · This submission: 179d
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 104
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K972959.
SYNERGY LT
K981405 · Oxford Instruments, Plc. · Jul 1998
MEDI-DX 7000 CPT WITH AMREX ELECTRODES
K980866 · Neuro-Diagnostic Assoc. · May 1998
AMPLAID MK12
K971740 · Amplifon S.P.A. · Mar 1998
EPOCH 2000 NEUROLOGICAL WORKSTATION
K971819 · Axon Systems, Inc. · Nov 1997
TECA. MILLENNIUM
K965065 · Medelec , Ltd. · Jun 1997
GALILEO EVOKED POTENTIALRE
K963662 · Biosound, Inc. · Feb 1997