Cleared Traditional

WHITE RIVER BATTERY-POWERED BREAST PUMP (K952712) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952712 · Natural Technologies, Inc. · Ophthalmic device
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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

Submission Details

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
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.

Device Classification

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 238
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K952712.
Spectra Platinum Mini
K260956 · Uzinmedicare Co., Ltd. · Jun 2026
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
K254300 · Anker Innovations Limited · May 2026
Wearable Breast Pump (Model S39)
K254244 · Shenzhen TPH Technology Co., Ltd. · May 2026
Electric Breast Pump (HL-3058 II Pro)
K254125 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · May 2026
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
K253914 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
K260239 · Jiangxi AOV Maternity & Baby Products Co., Ltd. · Apr 2026