Home / 510(k) Clearances / K241506

510(k) K241506

Annabella Double Breast Pump (ADO-US23-1000) by Annabella Tech — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2024
Date Received
May 28, 2024
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 for product code HGX

  • K253510 — Freestyle Mini Hands-free (April 10, 2026)
  • K260033 — Wearable Breast Pump (Model S21A) (April 8, 2026)
  • K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y- (April 8, 2026)
  • K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 (April 7, 2026)
  • K250208 — SPECTRA Wearable 2 (April 6, 2026)
  • K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (April 3, 2026)
  • K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (March 12, 2026)
  • K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, (March 9, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)