Cleared Traditional

K150499 - Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty

K150499 is an FDA 510(k) clearance for Freestyle Deluxe, manufactured by Medela AG. The device is a Class 2 Obstetrics & Gynecology device with 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

FDA 510(k) Submission Details - K150499

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
Combination Product No
PCCP Authorized No
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.

HGX Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Pathway Regulatory Consulting, LLC
ADRIENNE LENZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 202
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K150499.
ARDO Calypso Pro Powered Breast Pump
K150721 · Ardo Medical AG · Jun 2015
Electric Breast Pump
K143585 · Shantou Xinghe Electrical Apparatuses Co., Ltd. · May 2015
Melodi Prime Breast Pump
K143574 · Genadyne Biotechnologies, Inc. · Apr 2015
MEGNA BREAST PUMPS
K142479 · Wuxi Xinzhongrui Baby Supplies Co., Ltd. · Feb 2015
PJ'S SERENITY
K132220 · Limerick, Inc. · Feb 2015
NATURE'S BOND 600 AND NATURE'S BOND 603
K142168 · Devon Medical Products, Inc. · Dec 2014