Cleared Traditional

K141742 - ARDO CARUM AND CALYPSO POWERED BREAST PUMPS

K141742 is an FDA 510(k) clearance for ARDO CARUM AND CALYPSO POWERED BREAST PUMPS, 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 112-day FDA review.

K141742 · Ardo Medical AG · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Oct 2014
Decision
112d
Days
Class 2
Risk

K141742 is an FDA 510(k) clearance for the ARDO CARUM AND CALYPSO POWERED BREAST PUMPS. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Ardo Medical AG (Philedelphia, US). The FDA issued a Cleared decision on October 17, 2014 after a review of 112 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 - K141742

510(k) Number K141742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2014
Decision Date October 17, 2014
Days to Decision 112 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
49d faster than avg
Panel avg: 161d · This submission: 112d
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 Peers - HGX Pump, Breast, Powered

All 228
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K141742.
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
ELECTRIC BREAST PUMP
K132882 · Shantou Xinghe Electrical Apparatuses Co., Ltd. · Apr 2014
FREEMIE BREAST COLLECTION SYSTEM
K130349 · Dao Health · Sep 2013
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K131153 · Evenflo Feeding Incorporated · Jun 2013