Cleared Special

Rumble Tuff Electric Breast Pump (K200712) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K200712 · A Cute Baby, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
30d
Days
Class 2
Risk

K200712 is an FDA 510(k) clearance for the Rumble Tuff Electric Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by A Cute Baby, Inc. (Orem, US). The FDA issued a Cleared decision on April 17, 2020 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all A Cute Baby, Inc. devices

Submission Details

510(k) Number K200712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2020
Decision Date April 17, 2020
Days to Decision 30 days
Submission Type Special
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
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K200712.
Philips Avent Single/Double electric breast pump Advanced
K201381 · Philips Consumer Lifestyle - Innovation Site Eindhoven · Oct 2020
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
K193449 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Sep 2020
Pump In Style
K200508 · Medela, LLC · Jun 2020
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
K192640 · Guangzhou Yongyi Industrial Co., Ltd. · Mar 2020
Evolve Breast Pump
K200406 · Hygeia II Medical Group, Inc. · Mar 2020
Spectra Q
K191109 · Uzinmedicare Co. · Jan 2020