Cleared Traditional

K031614 - MEDELA PUMP IN STYLE ADVANCED BREAST PUMP

K031614 is the FDA 510(k) clearance for MEDELA PUMP IN STYLE ADVANCED BREAST PUMP by Medela, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGX) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K031614 · Medela, Inc. · Obstetrics & Gynecology device
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Jun 2003
Decision
14d
Days
Class 2
Risk

K031614 is an FDA 510(k) clearance for the MEDELA PUMP IN STYLE ADVANCED BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medela, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 6, 2003 after a review of 14 days - a notably fast clearance cycle.

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: 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 Medela, Inc. devices

Submission Details

510(k) Number K031614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2003
Decision Date June 06, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 160d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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.