Cleared Traditional

K150721 - ARDO Calypso Pro Powered Breast Pump

K150721 is an FDA 510(k) clearance for ARDO Calypso Pro Powered Breast Pump, manufactured by Ardo Medical AG. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K150721 · Ardo Medical AG · Obstetrics & Gynecology device
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Jun 2015
Decision
90d
Days
Class 2
Risk

K150721 is an FDA 510(k) clearance for the ARDO Calypso Pro Powered Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Ardo Medical AG (Unteraegeri, CH). The FDA issued a Cleared decision on June 17, 2015 after a review of 90 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.

View all Ardo Medical AG devices

FDA 510(k) Submission Details - K150721

510(k) Number K150721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2015
Decision Date June 17, 2015
Days to Decision 90 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
71d faster than avg
Panel avg: 161d · This submission: 90d
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

Hogan Lovells US LLP
YARMELA PAVLOVIC

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 228
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K150721.
Electric Double Breast Pumps
K151284 · Wuxi Xinzhongrui Baby Supplies Co., Ltd. · Dec 2015
Breast Pump
K150923 · Guangzhou Jinxinbao Electronic Co., Ltd. · Nov 2015
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
K151632 · Medela AG · Nov 2015
Electric Breast Pump
K143585 · Shantou Xinghe Electrical Apparatuses Co., Ltd. · May 2015
Melodi Prime Breast Pump
K143574 · Genadyne Biotechnologies, Inc. · Apr 2015
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
K150499 · Medela AG · Apr 2015