LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
FDA 510(k) K221810 · Bonraybio Co., Ltd.
510(k) numberK221810
Submission
- Device name
- LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
- Applicant
- Bonraybio Co., Ltd.
Taichung, TW - Received
- June 22, 2022
- Decision date
- October 31, 2022
- 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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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerPOV · Traditional | 05/30/2025SE |
| K242388 | LensHooke X12 PRO Semen Analysis SystemPOV · Traditional | 05/09/2025SE |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOV · Special | 10/28/2020SE |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerPOV · Traditional | 11/16/2018SE |
Questions and answers
When was LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device cleared by the FDA?
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device (K221810) received a 510(k) decision of Substantially Equivalent on October 31, 2022, 131 days after the submission was received.
What is the product code of K221810?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.