VitriGuard
FDA 510(k) K180740 · Origio A/S
510(k) numberK180740
Submission
- Device name
- VitriGuard
- Applicant
- Origio A/S
Måløv, DK - Received
- March 22, 2018
- Decision date
- May 4, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQK – Labware, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241626 | SperSort Sperm Sorting Chip (IPG02)MQK · Traditional | Ipreg Incorporation | 02/20/2025SE |
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB…MQK · Traditional | Guangzhou Hehong Biotech Co., Ltd. | 02/03/2025SE |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)MQK · Traditional | Motilitycount Aps | 01/31/2025SE |
| K241341 | cryo-GO Vitrification DeviceMQK · Traditional | Fujifilm Irvine Scientific | 09/26/2024SE |
| K240002 | G-Vitri Vitrification StrawMQK · Traditional | Gimbo Medical Technology Shenzhen Co., Ltd. | 06/14/2024SE |
| K232980 | SpermAlign Sperm Separation DeviceMQK · Traditional | Cytoswim, Ltd. | 03/14/2024SE |
| K233177 | Nest VT Vitrification DeviceMQK · Traditional | Cook Incorporated | 03/08/2024SE |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceMQK · Traditional | Bonraybio Co., Ltd. | 10/31/2022SE |
| K213869 | EmbryoSlide+ ic8 dishMQK · Traditional | Vitrolife A/S | 03/11/2022SE |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification StrawMQK · Traditional | Allwin Medical Devices, Inc. | 06/04/2021SE |
More from Allwin Medical Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200815 | VitriGuardMQK · Traditional | 06/25/2020SE |
| 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 |
| K133387 | Origio(R) Sequential Blast TM; Origio(R) Sequential Blast TM with Phenol RedMQL · Traditional | 04/29/2014SE |
Questions and answers
When was VitriGuard cleared by the FDA?
VitriGuard (K180740) received a 510(k) decision of Substantially Equivalent on May 4, 2018, 43 days after the submission was received.
What is the product code of K180740?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.