Cleared Traditional

K913320 - MIL CM-II COAGULATION MACHINE (FDA 510(k) Clearance)

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

K913320 · Medical Innovations Corp. · Hematology device
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Jun 1992
Decision
327d
Days
Class 2
Risk

K913320 is an FDA 510(k) clearance for the MIL CM-II COAGULATION MACHINE. Classified as Timer, Clot, Automated (product code GKN), Class II - Special Controls.

Submitted by Medical Innovations Corp. (Kowloon, Hong Kong, HK). The FDA issued a Cleared decision on June 16, 1992 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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. Elevated predicate reliance profile. 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 Medical Innovations Corp. devices

Submission Details

510(k) Number K913320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date June 16, 1992
Days to Decision 327 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 113d · This submission: 327d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKN Timer, Clot, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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.