Cleared Traditional

Passio Pump Drainage System

K201404 · Bearpac Medical · Anesthesiology

Nov 2020

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K201404 is an FDA 510(k) clearance for the Passio Pump Drainage System, a Apparatus, Suction, Patient Care (Class II — Special Controls, product code DWM), submitted by Bearpac Medical (Moultonborough, US). The FDA issued a Cleared decision on November 20, 2020, 176 days after receiving the submission on May 28, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.

Submission Details

510(k) Number	K201404 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2020
Decision Date	November 20, 2020
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement