Cleared Traditional

K961638 - MEDILOG MPA-S

K961638 is an FDA 510(k) clearance for MEDILOG MPA-S, manufactured by Oxford Instruments Medical Systems. The device is a Class 2 Neurology device with product code OLV cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K961638 · Oxford Instruments Medical Systems · Neurology device
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Jan 1997
Decision
263d
Days
Class 2
Risk

K961638 is an FDA 510(k) clearance for the MEDILOG MPA-S. Classified as Standard Polysomnograph With Electroencephalograph (product code OLV), Class II - Special Controls.

Submitted by Oxford Instruments Medical Systems (Clearwater, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 263 days - an extended review 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: 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 Oxford Instruments Medical Systems devices

FDA 510(k) Submission Details - K961638

510(k) Number K961638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1996
Decision Date January 17, 1997
Days to Decision 263 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 148d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - OLV Standard Polysomnograph With Electroencephalograph

All 33
Devices cleared under the same product code (OLV) and FDA review panel - the closest regulatory comparables to K961638.
EMBLA
K971813 · Ferguson Medical · Jan 1998
ALICE 4R SYSTEM
K971867 · Healthdyne Technologies, Inc. · Aug 1997
GRASS BRAINWAVE SOFTWARE
K970951 · Astro-Med, Inc. · May 1997
ALICE
K922106 · Healthdyne, Inc. · Jul 1994
ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP.
K860458 · Oxford Medilog, Inc. · Aug 1986
4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH
K854665 · Nihon Kohden America, Inc. · Jun 1986