Cleared Traditional

Passio Pump Drainage System

K190292 · Bearpac Medical · Anesthesiology

Jul 2019

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K190292 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 July 25, 2019, 164 days after receiving the submission on February 11, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.

Submission Details

510(k) Number	K190292 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2019
Decision Date	July 25, 2019
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement