Cleared Traditional

K202862 - Gx-IVF

K202862 is the FDA 510(k) clearance for Gx-IVF by Vitrolife Sweden AB. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K202862 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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May 2021
Decision
228d
Days
Class 2
Risk

K202862 is an FDA 510(k) clearance for the Gx-IVF, Gx-TL, Gx-MOPS PLUS. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Västra Frölunda, SE). The FDA issued a Cleared decision on May 14, 2021 after a review of 228 days - an extended review cycle.

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. Standard predicate reliance. 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 Vitrolife Sweden AB devices

Submission Details

510(k) Number K202862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date May 14, 2021
Days to Decision 228 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
68d slower than avg
Panel avg: 160d · This submission: 228d
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 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K202862.
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
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
K212410 · Shenzhen Vitavitro Biotech Co., Ltd. · Feb 2022
V-ONESTEP
K193285 · Vitromed GmbH · Nov 2020
GM501 Wash with Phenol Red and Gentamicin
K192503 · Hamilton Thorne Incorporated · Nov 2020
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
K200249 · Kitazato Corporation · Oct 2020