Cleared Traditional

GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (K902552) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K902552 · Gerber Products Co. · Obstetrics & Gynecology device
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Sep 1990
Decision
110d
Days
Class 1
Risk

K902552 is an FDA 510(k) clearance for the GERBER PRECIOUS CARE ELECTRIC BREAST PUMP. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Gerber Products Co. (Fremont, US). The FDA issued a Cleared decision on September 26, 1990 after a review of 110 days - within the typical 510(k) review window.

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: 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 Gerber Products Co. devices

Submission Details

510(k) Number K902552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1990
Decision Date September 26, 1990
Days to Decision 110 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
50d faster than avg
Panel avg: 160d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.