Cleared Traditional

V-ONESTEP (K193285) - FDA 510(k) Clearance

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

K193285 · Vitromed GmbH · Obstetrics & Gynecology device
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Nov 2020
Decision
359d
Days
Class 2
Risk

K193285 is an FDA 510(k) clearance for the V-ONESTEP. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitromed GmbH (Jena, DE). The FDA issued a Cleared decision on November 20, 2020 after a review of 359 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 Vitromed GmbH devices

Submission Details

510(k) Number K193285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2019
Decision Date November 20, 2020
Days to Decision 359 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
199d slower than avg
Panel avg: 160d · This submission: 359d
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 Consultant

Regulatory Specialists, Inc.
Robyn Scopis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQL Media, Reproductive

All 50
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K193285.
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
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Gx-IVF, Gx-TL, Gx-MOPS PLUS
K202862 · Vitrolife Sweden AB · May 2021
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
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
K200408 · Shenzhen Vitavitro Biotech Co., Ltd. · Oct 2020