Cleared Traditional

K050313 - BIS SRS (SEMI-RESUABLE SENSOR)

K050313 is an FDA 510(k) clearance for BIS SRS (SEMI-RESUABLE SENSOR), manufactured by Aspect Medical Systems, Inc.. The device is a Class 1 Neurology device with product code GWY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K050313 · Aspect Medical Systems, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K050313

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
Combination Product No
PCCP Authorized No
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.

GWY Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Entela, Inc.

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.