Cleared Traditional

K955577 - ECLIPSE VERSION 3.0

K955577 is an FDA 510(k) clearance for ECLIPSE VERSION 3.0, manufactured by Stellate Systems. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K955577 · Stellate Systems · Neurology device
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Sep 1996
Decision
317d
Days
Class 2
Risk

K955577 is an FDA 510(k) clearance for the ECLIPSE VERSION 3.0. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Stellate Systems (Canada, H32 2n2, CA). The FDA issued a Cleared decision on September 20, 1996 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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.

View all Stellate Systems devices

FDA 510(k) Submission Details - K955577

510(k) Number K955577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1995
Decision Date September 20, 1996
Days to Decision 317 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
169d slower than avg
Panel avg: 148d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 30
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K955577.
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
K000892 · Datex-Ohmeda, Inc. · Jun 2000
SIEMENS INFINITY EEG POD
K991012 · Siemens Medical Solutions USA, Inc. · Jun 1999
LUNA
K982351 · Stellate Systems · Jul 1998
DG PORTABLE SYSTEM
K954157 · Medelec , Ltd. · Jan 1996
A-1050 EEG MONITOR
K952347 · Aspect Medical Systems, Inc. · Jan 1996
TOPOGRAPHIC BRAIN MAPPING OPTION
K934050 · Biosound, Inc. · Feb 1994