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510(k) K200712

Rumble Tuff Electric Breast Pump by A Cute Baby, Inc. — Product Code HGX

K200712 is an FDA 510(k) premarket notification submitted by A Cute Baby, Inc. for the device "Rumble Tuff Electric Breast Pump". The FDA issued a decision of Substantially Equivalent on Apr 17, 2020. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. A Cute Baby, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 17, 2020
Date Received
Mar 18, 2020
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

Other clearances by A Cute Baby, Inc.

  • K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (Mar 12, 2026)

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: SCF5 (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