Cleared Traditional

K233394 - Gem Flow Now (GEM2770-FN)

K233394 is an FDA 510(k) clearance for Gem Flow Now (GEM2770-FN), manufactured by Synovis Micro Companies Alliance. The device is a Class 2 Cardiovascular device with product code IYN cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K233394 · Synovis Micro Companies Alliance · Cardiovascular device
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Jan 2024
Decision
117d
Days
Class 2
Risk

K233394 is an FDA 510(k) clearance for the Gem Flow Now (GEM2770-FN). 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 Synovis Micro Companies Alliance (Birmingham, US). The FDA issued a Cleared decision on January 28, 2024 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1550 - the FDA cardiovascular device 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Synovis Micro Companies Alliance devices

FDA 510(k) Submission Details - K233394

510(k) Number K233394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2023
Decision Date January 28, 2024
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 Cardiovascular devices follow this clearance model.

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

All 892
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K233394.
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