Cleared Traditional

K941462 - CARDIOVIT AT-5C (FDA 510(k) Clearance)

K941462 · Schiller America, Inc. · Cardiovascular device
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May 1995
Decision
421d
Days
-
Risk

K941462 is an FDA 510(k) clearance for the CARDIOVIT AT-5C.

Submitted by Schiller America, Inc. (Tustin, US). The FDA issued a Cleared decision on May 19, 1995 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

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Submission Details

510(k) Number K941462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date May 19, 1995
Days to Decision 421 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 125d · This submission: 421d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -