Cleared Traditional

K052909 - EVENFLO ELAN BREAST PUMP

K052909 is an FDA 510(k) clearance for EVENFLO ELAN BREAST PUMP, manufactured by Evenflo Company, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K052909 · Evenflo Company, Inc. · Obstetrics & Gynecology device
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Nov 2005
Decision
15d
Days
Class 2
Risk

K052909 is an FDA 510(k) clearance for the EVENFLO ELAN BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Evenflo Company, Inc. (Vandalia, US). The FDA issued a Cleared decision on November 1, 2005 after a review of 15 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 - K052909

510(k) Number K052909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2005
Decision Date November 01, 2005
Days to Decision 15 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 161d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENESEN

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 237
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K052909.
PLAYTEX EMBRACE PETITE BREAST PUMP
K061013 · Playtex Products, Inc. · Aug 2006
MEDELA SWING BREAST PUMP
K053052 · Medela AG · May 2006
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
K051926 · Limerick, Inc. · Dec 2005
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
K052047 · Avent America, Inc. · Sep 2005
WHITTLESTONE EXPRESSER
K051112 · Whittlestone, Inc. · Sep 2005
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
K051413 · Avent America, Inc. · Aug 2005

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K052909 · EVENFLO ELAN BREAST PUMP
Download PDF Evenflo Company, Inc.