Home / 510(k) Clearances / K112856

510(k) K112856

LUCINA-MELODI by Genadyne Biotechnologies, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2012
Date Received
September 30, 2011
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 Genadyne Biotechnologies, Inc.

  • K253429 — Genadyne ASTRA NPWT (March 12, 2026)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)
  • K233614 — Genadyne DUO NPWT (December 23, 2024)
  • K221888 — Genadyne Hybrid Foam Dressings (June 12, 2023)
  • K221891 — UNO Negative Pressure Wound Therapy System (December 14, 2022)
  • K210107 — Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (June 1, 2022)
  • K190028 — UNO 30 (January 15, 2020)
  • K182722 — XLR8 Abdominal Wound Dressing Kit (September 27, 2019)
  • K180840 — UNO Negative Pressure Wound Therapy System (November 30, 2018)
  • K161599 — UNO Negative Pressure Wound Therapy System (April 6, 2017)

Other clearances for product code HGX

  • 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)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 P (December 23, 2025)
  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)
  • K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (December 19, 2025)