Cleared Traditional

K131153 - EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP

K131153 is an FDA 510(k) clearance for EVENFLO ADVANCED DOUBLE ELECTRIC BREAST..., manufactured by Evenflo Feeding Incorporated. 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.

K131153 · Evenflo Feeding Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
55d
Days
Class 2
Risk

K131153 is an FDA 510(k) clearance for the EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Evenflo Feeding Incorporated (West Chester, US). The FDA issued a Cleared decision on June 18, 2013 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 Evenflo Feeding Incorporated devices

FDA 510(k) Submission Details - K131153

510(k) Number K131153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date June 18, 2013
Days to Decision 55 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
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. 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 Peers - HGX Pump, Breast, Powered

All 150
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K131153.
Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
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