Cleared Traditional

K971231 - WHITE RIVER MINI MANUAL BREAST PUMP

K971231 is an FDA 510(k) clearance for WHITE RIVER MINI MANUAL BREAST PUMP, manufactured by White River Concepts. The device is a Class 1 Obstetrics & Gynecology device with product code HGY cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K971231 · White River Concepts · Obstetrics & Gynecology device
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May 1997
Decision
46d
Days
Class 1
Risk

K971231 is an FDA 510(k) clearance for the WHITE RIVER MINI MANUAL BREAST PUMP. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by White River Concepts (San Clemente, US). The FDA issued a Cleared decision on May 19, 1997 after a review of 46 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all White River Concepts devices

FDA 510(k) Submission Details - K971231

510(k) Number K971231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1997
Decision Date May 19, 1997
Days to Decision 46 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 160d · This submission: 46d
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 9
Devices cleared under the same product code (HGY) and FDA review panel - the closest regulatory comparables to K971231.
AMEDA HYGIENIKIT
K011519 · Hollister, Inc. · Aug 2001
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