Cleared Special

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

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

Apr 2020

Decision

30d

Days

Class 2

Risk

K200712 is an FDA 510(k) clearance for the Rumble Tuff Electric Breast Pump. This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.5160.

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