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510(k) K112856

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

K112856 is an FDA 510(k) premarket notification submitted by Genadyne Biotechnologies, Inc. for the device "LUCINA-MELODI". The FDA issued a decision of Substantially Equivalent on May 10, 2012. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Genadyne Biotechnologies, Inc. has at least 10 other 510(k) clearances on record.

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

  • 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)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)
  • K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11 (June 12, 2026)
  • K250129 — AViTA Breast Pump (June 11, 2026)
  • K260864 — Mother's Nature W1 Warming Wearable Breast Pump (June 9, 2026)
  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)

FDA data resources