Cleared Special

Rumble Tuff Electric Breast Pump

K200712 · A Cute Baby, Inc. · Obstetrics & Gynecology

Apr 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K200712 is an FDA 510(k) clearance for the Rumble Tuff Electric Breast Pump, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by A Cute Baby, Inc. (Orem, US). The FDA issued a Cleared decision on April 17, 2020, 30 days after receiving the submission on March 18, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number	K200712 FDA.gov
FDA Decision	Cleared 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