Cleared Traditional

K113315 - RUMBLE TUFF

K113315 is an FDA 510(k) clearance for RUMBLE TUFF, manufactured by Acute Ideas Co. , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K113315 · Acute Ideas Co. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
377d
Days
Class 2
Risk

K113315 is an FDA 510(k) clearance for the RUMBLE TUFF. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Acute Ideas Co. , Ltd. (Orem, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K113315

510(k) Number K113315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2011
Decision Date November 20, 2012
Days to Decision 377 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 161d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 238
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K113315.
MEMORY PUMP MODEL Y4947
K131027 · Tomy International · May 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
CLOSER TO NATURE
K121322 · Mayborn Group Limited · May 2012
LUCINA-MELODI
K112856 · Genadyne Biotechnologies, Inc. · May 2012
CLOSER TO NATURE ELECTRIC BREAST PUMP
K113664 · Mayborn Group Limited · Feb 2012
K113315 · RUMBLE TUFF
Download PDF FDA Summary Acute Ideas Co. , Ltd.