Cleared Traditional

BEL-GEN Cold Storage Solution (K221387) - FDA 510(k) Clearance

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

K221387 · Institut Georges Lopez · Gastroenterology & Urology device
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Jun 2022
Decision
32d
Days
Class 2
Risk

K221387 is an FDA 510(k) clearance for the BEL-GEN Cold Storage Solution. Classified as Set, Perfusion, Kidney, Disposable (product code KDL), Class II - Special Controls.

Submitted by Institut Georges Lopez (Lissieu, FR). The FDA issued a Cleared decision on June 14, 2022 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - the FDA gastroenterology and urology 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 Institut Georges Lopez devices

Submission Details

510(k) Number K221387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2022
Decision Date June 14, 2022
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDL Set, Perfusion, Kidney, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDL Set, Perfusion, Kidney, Disposable

Devices cleared under the same product code (KDL) and FDA review panel - the closest regulatory comparables to K221387.
OrganProtex HTK Solution
K241239 · Bridge TO Life, Ltd. · Jan 2025
PERF-GEN Pulsatile Perfusion Solution
K221386 · Institut Georges Lopez · Jun 2022
Servator M SALF Solution
K211842 · S.A.L.F. Spa · Dec 2021
Custodiol HTK Solution
K192408 · Dr. Franz Kohler Chemie GmbH · Apr 2020
PERFUSION TUBING SET
K760922 · Shiley, Inc. · Nov 1976