Cleared Traditional

K203137 - Venue Fit

K203137 is the FDA 510(k) clearance for Venue Fit by GE Medical Systems Ultrasound and Primary Care Diagnostics. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K203137 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device
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Dec 2020
Decision
70d
Days
Class 2
Risk

K203137 is an FDA 510(k) clearance for the Venue Fit. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Wauwatosa, US). The FDA issued a Cleared decision on December 29, 2020 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight 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 GE Medical Systems Ultrasound and Primary Care Diagnostics devices

Submission Details

510(k) Number K203137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2020
Decision Date December 29, 2020
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 107d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 786
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