V-Onestep
FDA 510(k) K193285 · Vitromed GmbH
510(k) numberK193285
Submission
- Device name
- V-Onestep
- Applicant
- Vitromed GmbH
Jena, DE - Received
- November 27, 2019
- Decision date
- November 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQL – Media, Reproductive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6180
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)MQL · Traditional | Cell Store (Beijing) Biotechnology Co., Ltd. | 08/28/2026SE |
| K260248 | Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 04/28/2026SE |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)MQL · Traditional | Casebioscience, Inc. | 02/20/2026SE |
| K250445 | Fast Warm - NXMQL · Traditional | Fujifilm Irvine Scientific | 09/12/2025SE |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 08/27/2025SE |
| K251305 | Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional | Kitazato Corporation | 08/26/2025SE |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional | Fertipro NV | 05/30/2025SE |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL · Traditional | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 04/10/2025SE |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)MQL · Traditional | Jiangsu Ruifuda Medical Device Co., Ltd. | 04/10/2025SE |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…MQL · Traditional | Casebioscience, Inc. | 03/21/2025SE |
More from Casebioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241833 | V-GradMQL · Traditional | 03/21/2025SE |
| K240176 | V-VITFREEZE and V-VITWARMMQL · Traditional | 09/13/2024SE |
| K232125 | V-PvpMQL · Traditional | 03/20/2024SE |
| K222606 | V-HyadaseMQL · Traditional | 05/26/2023SE |
| K223117 | V-Sperm WashMQL · Traditional | 01/31/2023SE |
| K192146 | V-DenupetMQH · Traditional | 01/28/2020SE |
Questions and answers
When was V-Onestep cleared by the FDA?
V-Onestep (K193285) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 359 days after the submission was received.
What is the product code of K193285?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.