Cleared Traditional

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) (K220715) - FDA 510(k) Clearance

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

K220715 · Artsmedia Denmark Aps · Obstetrics & Gynecology device
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Feb 2023
Decision
336d
Days
Class 2
Risk

K220715 is an FDA 510(k) clearance for the ARTSMedia In Vitro Culture Medium (AM-IVC Medium). Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Artsmedia Denmark Aps (Virum, DK). The FDA issued a Cleared decision on February 10, 2023 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Artsmedia Denmark Aps devices

Submission Details

510(k) Number K220715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2022
Decision Date February 10, 2023
Days to Decision 336 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 160d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQL Media, Reproductive

All 50
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K220715.
Dewin Blastocyst Medium (with HSA and without HSA)
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V-SPERM WASH
K223117 · Vitromed GmbH · Jan 2023
V-HEPES PLUS
K213293 · Vitromed Langenfeld · Sep 2022
Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
K212426 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Jun 2022