ICSI-100
FDA 510(k) K043116 · Vitrolife Sweden AB
510(k) numberK043116
Submission
- Device name
- ICSI-100
- Applicant
- Vitrolife Sweden AB
Kungsbacka, SE - Received
- November 10, 2004
- Decision date
- January 13, 2005
- 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 |
|---|---|---|
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…MQF · Traditional | 07/23/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | 08/30/2024SE |
| K240605 | Ultra RapidWarm BlastMQL · Traditional | 08/07/2024SE |
| K202862 | Gx-IVF, Gx-TL, Gx-MOPS PLUSMQL · Traditional | 05/14/2021SE |
| K183486 | RapidVit Oocyte, RapidWarm OocyteMQL · Traditional | 07/26/2019SE |
| K181461 | Rapid-i KitMQK · Traditional | 01/04/2019SE |
| K172050 | Follicle Aspiration Set, Reduced Single LumenMQE · Traditional | 11/21/2017SE |
| K161970 | Follicle Aspiration SetMQE · Traditional | 06/14/2017SE |
| K150950 | FreezeKit Cleave , ThawKit CleaveMQL · Traditional | 12/21/2015SE |
| K140207 | Rapid-I KitMQK · Traditional | 12/18/2014SE |
Questions and answers
When was ICSI-100 cleared by the FDA?
ICSI-100 (K043116) received a 510(k) decision of Substantially Equivalent on January 13, 2005, 64 days after the submission was received.
What is the product code of K043116?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.