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510(k) K161725

Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail by Medela, Inc. — Product Code HGX

K161725 is an FDA 510(k) premarket notification submitted by Medela, Inc. for the device "Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail". The FDA issued a decision of Substantially Equivalent on October 28, 2016. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Medela, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2016
Date Received
June 22, 2016
Clearance Type
Traditional
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

Other clearances by Medela, Inc.

  • K253510 — Freestyle Mini Hands-free (April 10, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K251377 — Magic InBra (September 18, 2025)
  • K232608 — Duo Hands-free Breast Pump (April 12, 2024)
  • K223388 — Invia® Integrated Dressing (July 7, 2023)
  • K214112 — Invia Ease Negative Pressure Wound Therapy (NPWT) System (July 26, 2022)
  • K210759 — Solo, Swing Maxi (August 11, 2021)
  • K200508 — Pump In Style (June 15, 2020)
  • K191653 — Freestyle Flex (October 17, 2019)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (September 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (September 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
  • K260643 — Cimilre Dual Max (August 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (August 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)

FDA data resources