Cleared Traditional

K131027 - MEMORY PUMP MODEL Y4947

K131027 is an FDA 510(k) clearance for MEMORY PUMP MODEL Y4947, manufactured by Tomy International. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K131027 · Tomy International · Obstetrics & Gynecology device
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May 2013
Decision
48d
Days
Class 2
Risk

K131027 is an FDA 510(k) clearance for the MEMORY PUMP MODEL Y4947. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Tomy International (Canton, US). The FDA issued a Cleared decision on May 30, 2013 after a review of 48 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 - K131027

510(k) Number K131027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2013
Decision Date May 30, 2013
Days to Decision 48 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
113d faster than avg
Panel avg: 161d · This submission: 48d
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.
JEFF D RONGERO

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 235
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K131027.
ELECTRIC BREAST PUMP
K132882 · Shantou Xinghe Electrical Apparatuses Co., Ltd. · Apr 2014
FREEMIE BREAST COLLECTION SYSTEM
K130349 · Dao Health · Sep 2013
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K131153 · Evenflo Feeding Incorporated · Jun 2013
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
K121478 · Mapa GmbH · Apr 2013
LANSINOH POWERED ELECTRIC BREAST PUMP
K122474 · Lansinoh Laboratories Saglik Gerecleri Tasarim San · Dec 2012
RUMBLE TUFF
K113315 · Acute Ideas Co. , Ltd. · Nov 2012

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.