SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
FDA 510(k) K241348 · Motilitycount Aps
510(k) numberK241348
Submission
- Device name
- SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- Applicant
- Motilitycount Aps
Valby, DK - Received
- May 13, 2024
- Decision date
- January 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| K241341 | cryo-GO Vitrification DeviceMQK · Traditional | Fujifilm Irvine Scientific | 09/26/2024SE |
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| K232980 | SpermAlign Sperm Separation DeviceMQK · Traditional | Cytoswim, Ltd. | 03/14/2024SE |
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| 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 |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mLMQK · Traditional | Hertart Aps | 12/16/2020SE |
More from Hertart Aps
| 510(k) | Device | Decision |
|---|---|---|
| K183602 | SwimCount Sperm Quality TestPOV · Traditional | 06/27/2019SE |
Questions and answers
When was SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) cleared by the FDA?
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) (K241348) received a 510(k) decision of Substantially Equivalent on January 31, 2025, 263 days after the submission was received.
What is the product code of K241348?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.