Cleared Traditional

K913320 - MIL CM-II COAGULATION MACHINE

K913320 is an FDA 510(k) clearance for MIL CM-II COAGULATION MACHINE, manufactured by Medical Innovations Corp.. The device is a Class 2 Hematology device with product code GKN cleared through the Traditional 510(k) pathway after a 327-day FDA review.

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

FDA 510(k) Submission Details - K913320

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
Combination Product No
PCCP Authorized No
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.

GKN Device Classification - Class 2, Special Controls

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.