Cleared Special

GEM FLOW COUPLER Monitor (GEM1020M-2) (K213974) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213974 · Synovis Micro Companies Alliance, Inc. · General & Plastic Surgery device
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Apr 2022
Decision
121d
Days
Class 2
Risk

K213974 is an FDA 510(k) clearance for the GEM FLOW COUPLER Monitor (GEM1020M-2). Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Synovis Micro Companies Alliance, Inc. (Birmingham, US). The FDA issued a Cleared decision on April 20, 2022 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2100 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synovis Micro Companies Alliance, Inc. devices

Submission Details

510(k) Number K213974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2021
Decision Date April 20, 2022
Days to Decision 121 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 26
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