Cleared Traditional

K013863 - CRYSTAL MONITOR MODEL 16

K013863 is an FDA 510(k) clearance for CRYSTAL MONITOR MODEL 16, manufactured by Cleveland Medical Devices, Inc.. The device is a Class 2 Neurology device with product code OMC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013863 · Cleveland Medical Devices, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
90d
Days
Class 2
Risk

K013863 is an FDA 510(k) clearance for the CRYSTAL MONITOR MODEL 16. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Cleveland Medical Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 19, 2002 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 882.1400 - 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. 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 Cleveland Medical Devices, Inc. devices

FDA 510(k) Submission Details - K013863

510(k) Number K013863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date February 19, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

OMC Device Classification - Class 2, Special Controls

Product Code OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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 - OMC Reduced- Montage Standard Electroencephalograph

All 16
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K013863.
AE-120A EEG Head Set
K183529 · Nihon Kohden Corporation · Mar 2019
ENVOY PATIENT MONITOR
K024245 · Mennen Medical , Ltd. · May 2004
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
K020335 · Olympic Medical Corp. · Jun 2002
CRYSTAL-EEG MODEL 10 (MODEL 10)
K970672 · Cleveland Medical Devices, Inc. · May 1997
ACCESSORY TO ECG ANALYSIS SYS.
K781130 · Oxford Medilog, Inc. · Aug 1978