Cleared Traditional

K791852 - T-PC FOR R.F. M.D., M-501 (FDA 510(k) Clearance)

K791852 · Mem Medical, Inc. · Cardiovascular device
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Oct 1979
Decision
12d
Days
-
Risk

K791852 is an FDA 510(k) clearance for the T-PC FOR R.F. M.D., M-501.

Submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Cardiovascular 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 Mem Medical, Inc. devices

Submission Details

510(k) Number K791852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1979
Decision Date October 01, 1979
Days to Decision 12 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -