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510(k) K964403

SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) by The First Years, Inc. — Product Code HGX

K964403 is an FDA 510(k) premarket notification submitted by The First Years, Inc. for the device "SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)". The FDA issued a decision of Substantially Equivalent on January 13, 1997. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. The First Years, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1997
Date Received
November 4, 1996
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 The First Years, Inc.

  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (April 5, 2004)
  • K033131 — NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 (October 30, 2003)
  • K032566 — NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP (September 15, 2003)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (September 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (September 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
  • K260643 — Cimilre Dual Max (August 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (August 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • 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)

FDA data resources