Cleared Traditional

K944115 - HEPARIN ASSAY CARTRIDGES AND CONTROLS (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944115 · Medtronic Hemotec, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
213d
Days
Class 2
Risk

K944115 is an FDA 510(k) clearance for the HEPARIN ASSAY CARTRIDGES AND CONTROLS. Classified as Protamine Sulphate (product code GFT), Class II - Special Controls.

Submitted by Medtronic Hemotec, Inc. (Englewood, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 213 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Hemotec, Inc. devices

Submission Details

510(k) Number K944115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1994
Decision Date March 24, 1995
Days to Decision 213 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 113d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GFT Protamine Sulphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.