ARDO Bellis
FDA 510(k) K230590 · Ardo Medical AG
510(k) numberK230590
Submission
- Device name
- ARDO Bellis
- Applicant
- Ardo Medical AG
Unteraegeri, CH - Received
- March 3, 2023
- Decision date
- March 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGX – Pump, Breast, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional | Philips Consumer Lifestyle B.V. | 09/03/2026SE |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional | Guangdong Horigen Mother & Baby Products Co., Ltd. | 09/01/2026SE |
| K260643 | Cimilre Dual MaxHGX · Traditional | Cimilre Co., Ltd. | 08/21/2026SE |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional | Guangdong Youmeng Electrical Technology Co., Ltd. | 08/20/2026SE |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/24/2026SE |
| K261199 | Wearable Breast Pump (Model S32A)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/13/2026SE |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)HGX · Traditional | Shenzhen Changkun Technology Co., Ltd. | 06/26/2026SE |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional | Shenzhen Qinyi Electronic Technology Co., Ltd. | 06/25/2026SE |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/18/2026SE |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/17/2026SE |
More from Shenzhen Root Innovation Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K212773 | ARDO AlyssaHGX · Traditional | 04/15/2022SE |
| K172067 | One Mum PumpsetHGX · Special | 11/29/2017SE |
| K150721 | ARDO Calypso Pro Powered Breast PumpHGX · Traditional | 06/17/2015SE |
| K141742 | Ardo Carum and Calypso Powered Breast PumpsHGX · Traditional | 10/17/2014SE |
| K011601 | Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XXBTA · Traditional | 06/08/2001SE |
Questions and answers
When was ARDO Bellis cleared by the FDA?
ARDO Bellis (K230590) received a 510(k) decision of Substantially Equivalent on March 30, 2023, 27 days after the submission was received.
What is the product code of K230590?
The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.