Cleared Traditional

K812052 - MYOCATH CATOLOG NO. MCK-A (FDA 510(k) Clearance)

K812052 · Sorensen Research · Physical Medicine device
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Oct 1981
Decision
77d
Days
-
Risk

K812052 is an FDA 510(k) clearance for the MYOCATH CATOLOG NO. MCK-A.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on October 6, 1981 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Physical Medicine 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.

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Submission Details

510(k) Number K812052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date October 06, 1981
Days to Decision 77 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -