Cleared Traditional

K053052 - MEDELA SWING BREAST PUMP

K053052 is an FDA 510(k) clearance for MEDELA SWING BREAST PUMP, manufactured by Medela AG. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K053052 · Medela AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
183d
Days
Class 2
Risk

K053052 is an FDA 510(k) clearance for the MEDELA SWING BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on May 2, 2006 after a review of 183 days - an extended review 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: 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 - K053052

510(k) Number K053052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2005
Decision Date May 02, 2006
Days to Decision 183 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 161d · This submission: 183d
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

Tuv America, Inc.
STEFAN PREISS

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 254
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K053052.
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
K082307 · Evenflo Company, Inc. · Sep 2008
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
K070435 · Whittlestone, Inc. · Jul 2007
PLAYTEX EMBRACE PETITE BREAST PUMP
K061013 · Playtex Products, Inc. · Aug 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
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
K052047 · Avent America, Inc. · Sep 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.

K053052 · MEDELA SWING BREAST PUMP
Download PDF FDA Summary Medela AG