Cleared Traditional

K233394 - Gem Flow Now (GEM2770-FN) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233394 · Synovis Micro Companies Alliance · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 Cardiovascular devices follow this clearance model.

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

All 1158
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K233394.
ES-Series
K260589 · E-Scopics · Apr 2026
6450 Ultrasound System (MyLabE80)
K253288 · Esaote, S.P.A. · Apr 2026
Wireless Probe Type Ultrasound Scanner
K252709 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Apr 2026
EVO Q30 Diagnostic Ultrasound System
K254099 · Samsung Medison Co., Ltd. · Mar 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
K253595 · Philips Ultrasound, LLC · Mar 2026
Butterfly Gestational Age Tool
K252148 · Butterfly Network, Inc. · Mar 2026