Vacuum Pump (Model: AD-VPUM-500)
FDA 510(k) K260194 · Sheng Sheng Yi (Beijing) Technology Company Limited
510(k) numberK260194
Submission
- Device name
- Vacuum Pump (Model: AD-VPUM-500)
- Applicant
- Sheng Sheng Yi (Beijing) Technology Company Limited
Beijing, CN - Received
- January 22, 2026
- Decision date
- April 28, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQG – Accessory, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6120
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | CooperSurgical, Inc. | 08/19/2026SE |
| K242684 | Harioculture TL-16 Time-lapse IncubatorMQG · Traditional | Hua Yue Medical Technology Co., Ltd. | 05/22/2025SE |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)MQG · Traditional | Wuhan Huchuang Union Technology Co., Ltd. | 05/07/2024SE |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 06/07/2018SE |
| K173264 | EmbryoScope+MQG · Traditional | Vitrolife A/S | 05/11/2018SE |
| K180304 | Geri Embryo Incubator and Geri DishMQG · Special | Genea Biomedx Pty, Ltd. | 04/20/2018SE |
| K171736 | Geri Embryo Incubator and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 11/15/2017SE |
| K160753 | COOK Vacuum PumpMQG · Traditional | William A. Cook Australia Pty. , Ltd. | 06/13/2017SE |
| K160504 | RI Witness Embryology Heated PlateMQG · Traditional | Research Instruments Limited | 07/18/2016SE |
| K151357 | Miri TLMQG · Traditional | At Medical Uab | 04/22/2016SE |
Questions and answers
When was Vacuum Pump (Model: AD-VPUM-500) cleared by the FDA?
Vacuum Pump (Model: AD-VPUM-500) (K260194) received a 510(k) decision of Substantially Equivalent on April 28, 2026, 96 days after the submission was received.
What is the product code of K260194?
The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.