Cleared Traditional

DISK (K812695) - FDA 510(k) Clearance

K812695 · American Heartline, Inc. · Cardiovascular device
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Oct 1981
Decision
21d
Days
-
Risk

K812695 is an FDA 510(k) clearance for the DISK.

Submitted by American Heartline, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 21 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 American Heartline, Inc. devices

Submission Details

510(k) Number K812695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1981
Decision Date October 13, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -