Cleared Traditional

K123987 - IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
(FDA 510(k) Clearance)

K123987 · Innovative Medical Technologies, Inc. · General Hospital

Aug 2013

Decision

244d

Days

Class 2

Risk

K123987 is an FDA 510(k) clearance for the IMPROVE BLOOD COLLECTION SET AND IMPROSAFE 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. (Leawood, US). The FDA issued a Cleared decision on August 27, 2013, 244 days after receiving the submission on December 26, 2012.

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

Submission Details

510(k) Number	K123987 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2012
Decision Date	August 27, 2013
Days to Decision	244 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement