Cleared Traditional

K800843 - MEDEFIZZ A & MEDEFIZZ B (FDA 510(k) Clearance)

K800843 · Medefield Pty. , Ltd. · Radiology device
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Jun 1980
Decision
63d
Days
-
Risk

K800843 is an FDA 510(k) clearance for the MEDEFIZZ A & MEDEFIZZ B. Classified as Medium, Contrast, Radiologic (product code KTA).

Submitted by Medefield Pty. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1980 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. 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 Medefield Pty. , Ltd. devices

Submission Details

510(k) Number K800843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1980
Decision Date June 17, 1980
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTA Medium, Contrast, Radiologic
Device Class -