Isocare One Step Sperm Processing Medium Cat# 2207-12
FDA 510(k) K023222 · Invitrocare, Inc.
510(k) numberK023222
Submission
- Device name
- Isocare One Step Sperm Processing Medium Cat# 2207-12
- Applicant
- Invitrocare, Inc.
Frederick, MD, US - Received
- September 27, 2002
- Decision date
- December 26, 2002
- 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 |
|---|---|---|
| K003751 | Hyaluronidase Reagent, Model CAT#2212MQL · Traditional | 01/17/2001SE |
| K001967 | Pvp-Polyvinylpyrrolidone Reagent, Model CAT#2210MQL · Traditional | 08/14/2000SE |
| K001113 | Ivc Three Blastocyst Medium, Cat # 2007MQL · Traditional | 06/13/2000SE |
| K000989 | Sperm Wash Medium, Cat# 2003/2005MQL · Traditional | 06/08/2000SE |
| K993484 | Q-Htf, Cat# 2001MQL · Traditional | 05/25/2000SE |
| K000938 | Ivc One MediumMQL · Traditional | 05/25/2000SE |
| K000937 | Ivc Two MediumMQL · Traditional | 05/25/2000SE |
| K000940 | Human Serum Albumin (Hsa)MQL · Traditional | 05/04/2000SE |
| K000939 | Htf-HepesMQL · Traditional | 05/04/2000SE |
Questions and answers
When was Isocare One Step Sperm Processing Medium Cat# 2207-12 cleared by the FDA?
Isocare One Step Sperm Processing Medium Cat# 2207-12 (K023222) received a 510(k) decision of Substantially Equivalent on December 26, 2002, 90 days after the submission was received.
What is the product code of K023222?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.