Cleared Traditional

K925738 - WHITE RIVER MANUAL BREAST PUMP

K925738 is an FDA 510(k) clearance for WHITE RIVER MANUAL BREAST PUMP, manufactured by White River (Tm). The device is a Class 1 Obstetrics & Gynecology device with product code HGY cleared through the Traditional 510(k) pathway after a 537-day FDA review.

K925738 · White River (Tm) · Obstetrics & Gynecology device
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May 1994
Decision
537d
Days
Class 1
Risk

K925738 is an FDA 510(k) clearance for the WHITE RIVER MANUAL BREAST PUMP. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by White River (Tm) (Laguna Hills, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 537 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5150 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all White River (Tm) devices

FDA 510(k) Submission Details - K925738

510(k) Number K925738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1992
Decision Date May 04, 1994
Days to Decision 537 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
377d slower than avg
Panel avg: 160d · This submission: 537d
Pathway characteristics
Predicate-based equivalence.

HGY Device Classification - Class 1, General Controls

Product Code HGY Pump, Breast, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HGY Pump, Breast, Non-powered

All 10
Devices cleared under the same product code (HGY) and FDA review panel - the closest regulatory comparables to K925738.
WHITE RIVER MINI MANUAL BREAST PUMP
K971231 · White River Concepts · May 1997
EVERT-IT
K962828 · Genesis Industries, Inc. · Feb 1997
MEDELA'S FOOT PUMP
K952034 · Medela, Inc. · Sep 1995
MOTHERS TOUCH ONE HAND BREAST PUMP
K912355 · Hollister, Inc. · Dec 1993
SUPPLEMENTAL FEEDING SYSTEM
K844297 · Medela, Inc. · Feb 1985
NEW MOTHER'S WAY-BREAST PUMP
K834399 · Huntleigh Technology, Inc. · Jan 1984