Cleared Traditional

K780962 - AUTOMATED ENZYME (FDA 510(k) Clearance)

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

K780962 · Hyland Therapeutic Div., Travenol Laboratories · Hematology device
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Jul 1978
Decision
45d
Days
Class 2
Risk

K780962 is an FDA 510(k) clearance for the AUTOMATED ENZYME. Classified as Solution, Stabilized Enzyme (product code KSK), Class II - Special Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9400 - 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 Hyland Therapeutic Div., Travenol Laboratories devices

Submission Details

510(k) Number K780962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1978
Decision Date July 27, 1978
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 113d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSK Solution, Stabilized Enzyme
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9400
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.