Cleared Traditional

K850705 - THE WHITE RIVER PORTA-ELEC-BREAST PUMP

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

K850705 · Natural Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K850705

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 161d · This submission: 140d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 254
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K850705.
AXICARE CM-14 AUTOMATIC BREAST PUMP
K853107 · Crystal Medical Products, Inc. · Nov 1985
WATER DRIVEN BREAST PUMP BY BABY NURSE
K853326 · Baby Nurse · Nov 1985
GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
K852460 · Healthteam · Nov 1985
NATURAL MOTHER BREAST PUMP
K850753 · Crystal Medical Products, Inc. · Jun 1985
CARE ELECTRIC BREAST PUMP
K844013 · Hankscraft Div. of Gerber Products Co. · Feb 1985
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP
K844307 · Egnell, Inc. · Feb 1985
K850705 · THE WHITE RIVER PORTA-ELEC-BREAST PUMP
Download PDF Natural Technologies,…