Cleared Traditional

K161725 - Sonata Breastpump Deluxe

K161725 is the FDA 510(k) clearance for Sonata Breastpump Deluxe by Medela, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HGX) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K161725 · Medela, Inc. · Obstetrics & Gynecology device
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Oct 2016
Decision
128d
Days
Class 2
Risk

K161725 is an FDA 510(k) clearance for the Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing K.... 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 October 28, 2016 after a review of 128 days - within the typical 510(k) review window.

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: 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 K161725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2016
Decision Date October 28, 2016
Days to Decision 128 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
32d faster than avg
Panel avg: 160d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.