Cleared Traditional

K912355 - MOTHERS TOUCH ONE HAND BREAST PUMP (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K912355 · Hollister, Inc. · Obstetrics & Gynecology device
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Dec 1993
Decision
927d
Days
Class 1
Risk

K912355 is an FDA 510(k) clearance for the MOTHERS TOUCH ONE HAND BREAST PUMP. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Hollister, Inc. (Chicago, US). The FDA issued a Cleared decision on December 10, 1993 after a review of 927 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Hollister, Inc. devices

Submission Details

510(k) Number K912355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date December 10, 1993
Days to Decision 927 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
767d slower than avg
Panel avg: 160d · This submission: 927d
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.