Cleared Traditional

K952712 - WHITE RIVER BATTERY-POWERED BREAST PUMP

K952712 is an FDA 510(k) clearance for WHITE RIVER BATTERY-POWERED BREAST PUMP, manufactured by Natural Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code HGX cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K952712 · Natural Technologies, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
309d
Days
Class 2
Risk

K952712 is an FDA 510(k) clearance for the WHITE RIVER BATTERY-POWERED BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Natural Technologies, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 884.5160 - the FDA ophthalmic 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Natural Technologies, Inc. devices

FDA 510(k) Submission Details - K952712

510(k) Number K952712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1995
Decision Date April 18, 1996
Days to Decision 309 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 110d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 206
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K952712.
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
K960727 · Evenflo Co., Inc. · Feb 1997
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
K964403 · The First Years, Inc. · Jan 1997
EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
K960726 · Evenflo Co., Inc. · Jul 1996
MEDELAS BREAST PUMP
K950750 · Medela, Inc. · Oct 1995
EGNELL ELITE
K950531 · Hollister, Inc. · Sep 1995
MEDELA BATTERY OPERATED BREAST PUMP
K901344 · Medela, Inc. · Aug 1990