IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET— 510(k) K123987

Substantially Equivalent

Innovative Medical Technologies, Inc.

FDA 510(k) clearance K123987 for IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET, Substantially Equivalent on 2013-08-27. Applicant: Innovative Medical Technologies, Inc..

Clearance details

Applicant: Innovative Medical Technologies, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2012-12-26
Decision date: 2013-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leawood, KS, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.