Cleared Traditional

K150499 - Freestyle Deluxe

K150499 is the FDA 510(k) clearance for Freestyle Deluxe by Medela AG. It is a Class 2 Obstetrics & Gynecology device (product code HGX) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K150499 · Medela AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
54d
Days
Class 2
Risk

K150499 is an FDA 510(k) clearance for the Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Wa.... Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medela AG (Baar, CH). The FDA issued a Cleared decision on April 21, 2015 after a review of 54 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 AG devices

Submission Details

510(k) Number K150499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2015
Decision Date April 21, 2015
Days to Decision 54 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
106d faster than avg
Panel avg: 160d · This submission: 54d
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.