Cleared Traditional

K131027 - MEMORY PUMP MODEL Y4947 (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Tomy International devices

Submission Details

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
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 160d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 238
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