Cleared Traditional

K945286 - THE BAGNOLI-2 EMG SYSTEM

K945286 is an FDA 510(k) clearance for THE BAGNOLI-2 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 319-day FDA review.

K945286 · Delsys, Inc. · Neurology device
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Sep 1995
Decision
319d
Days
Class 2
Risk

K945286 is an FDA 510(k) clearance for the THE BAGNOLI-2 EMG SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Delsys, Inc. (Wellesley, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K945286

510(k) Number K945286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1994
Decision Date September 15, 1995
Days to Decision 319 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
170d slower than avg
Panel avg: 149d · This submission: 319d
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 143
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K945286.
BIOFEEDBACK DEVICE
K954127 · Verimed Holdings, Inc. · Nov 1995
RELAXPLUS
K951213 · Ultramind International , Ltd. · Sep 1995
A620 EEG
K944615 · Stoelting Co. · Sep 1995
BIOINTEGRATOR, BIOINTEGRATOR PLUS
K942769 · Bio Research Institute · Sep 1995
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995
MUSCLESENSE ELECTROMYOGRAPHY DEVICE
K951350 · Smith and Nephew Donjoy, Inc. · Jun 1995
K945286 · THE BAGNOLI-2 EMG SYSTEM
Download PDF Delsys, Inc.