Origio(R) Sequential Blast TM; Origio(R) Sequential Blast TM with Phenol Red
FDA 510(k) K133387 · Origio A/S
510(k) numberK133387
Submission
- Device name
- Origio(R) Sequential Blast TM; Origio(R) Sequential Blast TM with Phenol Red
- Applicant
- Origio A/S
Måløv, DK - Received
- November 5, 2013
- Decision date
- April 29, 2014
- 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 |
|---|---|---|
| K200815 | VitriGuardMQK · Traditional | 06/25/2020SE |
| K180740 | VitriGuardMQK · Special | 05/04/2018SE |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red…MQL · Traditional | 03/02/2018SE |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSMQL · Traditional | 10/13/2017SE |
| K161547 | Transem and EchoGen Embryo Transfer CathetersMQF · Traditional | 03/09/2017SE |
| K162833 | VitriGuardMQK · Traditional | 02/16/2017SE |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashMQL · Traditional | 07/22/2016SE |
| K152932 | BlastGenMQL · Traditional | 02/29/2016SE |
| K140317 | EmbryogenMQL · Traditional | 06/16/2014SE |
| K133912 | Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav…MQL · Traditional | 05/14/2014SE |
Questions and answers
When was Origio(R) Sequential Blast TM; Origio(R) Sequential Blast TM with Phenol Red cleared by the FDA?
Origio(R) Sequential Blast TM; Origio(R) Sequential Blast TM with Phenol Red (K133387) received a 510(k) decision of Substantially Equivalent on April 29, 2014, 175 days after the submission was received.
What is the product code of K133387?
The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.