Cleared Traditional

K050143 - OMNIPRO SYSTEM

K050143 is an FDA 510(k) clearance for OMNIPRO SYSTEM, manufactured by Mays and Associates, Inc.. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K050143 · Mays and Associates, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
11d
Days
Class 2
Risk

K050143 is an FDA 510(k) clearance for the OMNIPRO SYSTEM. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Mays and Associates, Inc. (Houston, US). The FDA issued a Cleared decision on February 1, 2005 after a review of 11 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K050143

510(k) Number K050143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2005
Decision Date February 01, 2005
Days to Decision 11 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 149d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

OLV Device Classification - Class 2, Special Controls

Product Code OLV Standard Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.
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 Consultant

Entela, Inc.
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLV Standard Polysomnograph With Electroencephalograph

All 64
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K050143.
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K042364 · Lamont Medical, Inc. · Sep 2004
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K050143 · OMNIPRO SYSTEM
Download PDF FDA Summary Mays and Associates, …