Cleared Traditional

K220458 - UltraFlo-R Push Button Blood Collection Set
(FDA 510(k) Clearance)

K220458 · Innovative Medical Technologies, Inc. · General Hospital

Sep 2023

Decision

589d

Days

Class 2

Risk

K220458 is an FDA 510(k) clearance for the UltraFlo-R Push Button Blood Collection Set. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA).

Submitted by Innovative Medical Technologies, Inc. (Omaha, US). The FDA issued a Cleared decision on September 29, 2023, 589 days after receiving the submission on February 17, 2022.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number	K220458 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2022
Decision Date	September 29, 2023
Days to Decision	589 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement