Cleared Traditional

K051413 - ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100

K051413 is an FDA 510(k) clearance for ISIS IQ DUO TWIN 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 90-day FDA review.

K051413 · Avent America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
90d
Days
Class 2
Risk

K051413 is an FDA 510(k) clearance for the ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100. 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 August 29, 2005 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.

FDA 510(k) Submission Details - K051413

510(k) Number K051413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2005
Decision Date August 29, 2005
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 Peers - HGX Pump, Breast, Powered

All 251
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K051413.
EVENFLO ELAN BREAST PUMP
K052909 · Evenflo Company, Inc. · Nov 2005
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
K052047 · Avent America, Inc. · Sep 2005
WHITTLESTONE EXPRESSER
K051112 · Whittlestone, Inc. · Sep 2005
GERBER DOUBLE ELECTRIC BREAST PUMP
K043098 · Gerber Products Co. · Dec 2004
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068
K033131 · The First Years, Inc. · Oct 2003
NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
K032566 · The First Years, Inc. · Sep 2003
K051413 · ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
Download PDF FDA Summary Avent America, Inc.