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510(k) K052047

ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 by Avent America, Inc. — Product Code HGX

K052047 is an FDA 510(k) premarket notification submitted by Avent America, Inc. for the device "ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101". The FDA issued a decision of Substantially Equivalent on September 22, 2005. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Avent America, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2005
Date Received
July 29, 2005
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 Avent America, Inc.

  • K051413 — ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 (August 29, 2005)
  • K952035 — NIPLETTE (July 28, 1995)
  • K944117 — AVENT NIPPLE SHIELD (October 5, 1994)

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