Cleared Traditional

DISC-PAK ROTATOR (K780544) - FDA 510(k) Clearance

Class I Hematology device.

K780544 · Techhnilab Instruments, Inc. · Hematology device
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Apr 1978
Decision
21d
Days
Class 1
Risk

K780544 is an FDA 510(k) clearance for the DISC-PAK ROTATOR. Classified as Mixer, Blood Tube (product code GLE), Class I - General Controls.

Submitted by Techhnilab Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1978 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - 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 Techhnilab Instruments, Inc. devices

Submission Details

510(k) Number K780544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1978
Decision Date April 24, 1978
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GLE Mixer, Blood Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.