Cleared Traditional

K850705 - THE WHITE RIVER PORTA-ELEC-BREAST PUMP

K850705 is the FDA 510(k) clearance for THE WHITE RIVER PORTA-ELEC-BREAST PUMP by Natural Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGX) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K850705 · Natural Technologies, Inc. · Obstetrics & Gynecology device
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Jul 1985
Decision
140d
Days
Class 2
Risk

K850705 is an FDA 510(k) clearance for the THE WHITE RIVER PORTA-ELEC-BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Natural Technologies, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 140 days - within the typical 510(k) review window.

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

View all Natural Technologies, Inc. devices

Submission Details

510(k) Number K850705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1985
Decision Date July 11, 1985
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 160d · This submission: 140d
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 Obstetrics & Gynecology devices follow this clearance model.