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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 161d · 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 251
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K052047.
MEDELA SWING BREAST PUMP
K053052 · Medela AG · May 2006
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
K051926 · Limerick, Inc. · Dec 2005
EVENFLO ELAN BREAST PUMP
K052909 · Evenflo Company, Inc. · Nov 2005
WHITTLESTONE EXPRESSER
K051112 · Whittlestone, Inc. · Sep 2005
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
K051413 · Avent America, Inc. · Aug 2005
GERBER DOUBLE ELECTRIC BREAST PUMP
K043098 · Gerber Products Co. · Dec 2004
K052047 · ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
Download PDF FDA Summary Avent America, Inc.