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510(k) K970488

HYDROCHECK MICRO FILTER by White River Concepts — Product Code HGX

K970488 is an FDA 510(k) premarket notification submitted by White River Concepts for the device "HYDROCHECK MICRO FILTER". The FDA issued a decision of Substantially Equivalent on November 4, 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 at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1997
Date Received
February 10, 1997
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 White River Concepts

  • K964679 — WHITE RIVER AUTOMATIC BREAST PUMP (June 10, 1997)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)

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