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510(k) K021739

LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 by Limerick, Inc. — Product Code HGX

K021739 is an FDA 510(k) premarket notification submitted by Limerick, Inc. for the device "LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002". The FDA issued a decision of Substantially Equivalent on Jan 10, 2003. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Limerick, Inc. has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 10, 2003
Date Received
May 28, 2002
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 Limerick, Inc.

  • K132220 — PJ'S SERENITY (Feb 20, 2015)
  • K051926 — LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP (Dec 12, 2005)
  • K012275 — PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP (Jan 7, 2002)

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 K021739. Report a data issue: hello@regdatalab.com.