Cleared Traditional

K981934 - THE BAGNOLI-4 EMG SYSTEM

K981934 is an FDA 510(k) clearance for THE BAGNOLI-4 EMG SYSTEM, manufactured by Delsys, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981934 · Delsys, Inc. · Neurology device
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Aug 1998
Decision
90d
Days
Class 2
Risk

K981934 is an FDA 510(k) clearance for the THE BAGNOLI-4 EMG SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Delsys, Inc. (Boston, US). The FDA issued a Cleared decision on August 31, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Delsys, Inc. devices

FDA 510(k) Submission Details - K981934

510(k) Number K981934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1998
Decision Date August 31, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 42
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K981934.
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
K990538 · Brainmaster · May 1999
THE BAGNOLI-8 EMG SYSTEM
K990356 · Delsys, Inc. · Apr 1999
XYZ SYSTEM
K983550 · Bio-Monitoring International Corp. · Jan 1999
SLEEP MANAGEMENT SYSTEM
K981844 · Rmp, Inc. · Aug 1998
ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
K980373 · Ultramind International , Ltd. · Apr 1998
MUSCLE RESPONSE MONITOR
K971400 · Enriching Your Life · Apr 1998