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510(k) K230590

ARDO Bellis by Ardo Medical AG — Product Code HGX

K230590 is an FDA 510(k) premarket notification submitted by Ardo Medical AG for the device "ARDO Bellis". The FDA issued a decision of Substantially Equivalent on Mar 30, 2023. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Ardo Medical AG has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 30, 2023
Date Received
Mar 3, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type
510(k)

Other clearances by Ardo Medical AG

  • K212773 — ARDO Alyssa (Apr 15, 2022)
  • K172067 — One Mum Pumpset (Nov 29, 2017)
  • K150721 — ARDO Calypso Pro Powered Breast Pump (Jun 17, 2015)
  • K141742 — ARDO CARUM AND CALYPSO POWERED BREAST PUMPS (Oct 17, 2014)
  • K011601 — ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL… (Jun 8, 2001)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (Jun 18, 2026)

FDA data resources