Cleared Traditional

K990356 - THE BAGNOLI-8 EMG SYSTEM

K990356 is an FDA 510(k) clearance for THE BAGNOLI-8 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 83-day FDA review.

K990356 · Delsys, Inc. · Neurology device
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Apr 1999
Decision
83d
Days
Class 2
Risk

K990356 is an FDA 510(k) clearance for the THE BAGNOLI-8 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 April 29, 1999 after a review of 83 days - a notably fast clearance cycle.

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: 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 Delsys, Inc. devices

FDA 510(k) Submission Details - K990356

510(k) Number K990356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date April 29, 1999
Days to Decision 83 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
65d faster than avg
Panel avg: 148d · This submission: 83d
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 K990356.
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XYZ SYSTEM
K983550 · Bio-Monitoring International Corp. · Jan 1999
THE BAGNOLI-4 EMG SYSTEM
K981934 · Delsys, Inc. · Aug 1998
SLEEP MANAGEMENT SYSTEM
K981844 · Rmp, Inc. · Aug 1998