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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 Sep 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 3 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 22, 2005
Date Received
Jul 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
510(k)

Other clearances by Avent America, Inc.

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

Other clearances for product code HGX

  • K261782 — MODO DUO Electric Pump (B11621, B11673) (Oct 16, 2026)
  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (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)

FDA data resources

Source: FDA 510(k) database entry for K052047. Report a data issue: hello@regdatalab.com.