Cleared Traditional

K052047 - ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101

K052047 is an FDA 510(k) clearance for ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, manufactured by Avent America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K052047 · Avent America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
55d
Days
Class 2
Risk

K052047 is an FDA 510(k) clearance for the ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Avent America, Inc. (Framingham, US). The FDA issued a Cleared decision on September 22, 2005 after a review of 55 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 Avent America, Inc. devices

FDA 510(k) Submission Details - K052047

510(k) Number K052047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date September 22, 2005
Days to Decision 55 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
105d faster than avg
Panel avg: 160d · This submission: 55d
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 175
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K052047.
TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
K110343 · Mayborn Baby and Child / Jackel International, Ltd. · Mar 2011
PLAYTEX EMBRACE PETITE BREAST PUMP
K061013 · Playtex Products, Inc. · Aug 2006
MEDELA SWING BREAST PUMP
K053052 · Medela AG · May 2006
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
K031614 · Medela, Inc. · Jun 2003
PLAYTEX BREAST PUMP
K022594 · Playtex Products, Inc. · Nov 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · Medela, Inc. · Mar 2002