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510(k) K964679

WHITE RIVER AUTOMATIC BREAST PUMP by White River Concepts — Product Code HGX

K964679 is an FDA 510(k) premarket notification submitted by White River Concepts for the device "WHITE RIVER AUTOMATIC BREAST PUMP". The FDA issued a decision of Substantially Equivalent on Jun 10, 1997. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. White River Concepts has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 10, 1997
Date Received
Nov 21, 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
510(k)

Other clearances by White River Concepts

  • K970488 — HYDROCHECK MICRO FILTER (Nov 4, 1997)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)

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 K964679. Report a data issue: hello@regdatalab.com.