Cleared Traditional

K802319 - HEMOTEMP TM (FDA 510(k) Clearance)

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

K802319 · Marion Laboratories, Inc. · Hematology device
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Oct 1980
Decision
17d
Days
Class 2
Risk

K802319 is an FDA 510(k) clearance for the HEMOTEMP TM. Classified as Refrigerator, Freezer, Blood Storage (product code KSE), Class II - Special Controls.

Submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marion Laboratories, Inc. devices

Submission Details

510(k) Number K802319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date October 10, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 113d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSE Refrigerator, Freezer, Blood Storage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9700
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.