Cleared Traditional

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (K101538) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K101538 · Philips Electronics UK Limited · Obstetrics & Gynecology device
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Nov 2010
Decision
155d
Days
Class 1
Risk

K101538 is an FDA 510(k) clearance for the HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP). Classified as Pump, Breast, Non-powered (product code HGY), Class I - General Controls.

Submitted by Philips Electronics UK Limited (Great Abington, Cambridge, GB). The FDA issued a Cleared decision on November 5, 2010 after a review of 155 days - an extended review 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: 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.

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Submission Details

510(k) Number K101538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date November 05, 2010
Days to Decision 155 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 160d · This submission: 155d
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.