Cleared Traditional

BIS SRS (SEMI-RESUABLE SENSOR) (K050313) - FDA 510(k) Clearance

Class I Neurology device.

K050313 · Aspect Medical Systems, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Feb 2005
Decision
15d
Days
Class 1
Risk

K050313 is an FDA 510(k) clearance for the BIS SRS (SEMI-RESUABLE SENSOR). Classified as Pinwheel (product code GWY), Class I - General Controls.

Submitted by Aspect Medical Systems, Inc. (Newton, US). The FDA issued a Cleared decision on February 24, 2005 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1750 - 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.

View all Aspect Medical Systems, Inc. devices

Submission Details

510(k) Number K050313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2005
Decision Date February 24, 2005
Days to Decision 15 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code GWY Pinwheel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.