Cleared Traditional

NIPLETTE (K952035) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K952035 · Avent America, Inc. · Obstetrics & Gynecology device
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Jul 1995
Decision
88d
Days
Class 1
Risk

K952035 is an FDA 510(k) clearance for the NIPLETTE. Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Avent America, Inc. (Addison, US). The FDA issued a Cleared decision on July 28, 1995 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avent America, Inc. devices

Submission Details

510(k) Number K952035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date July 28, 1995
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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.