Cleared Traditional

K914970 - CARDIOVIT CS-100 (FDA 510(k) Clearance)

K914970 · Schiller America, Inc. · Cardiovascular device
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Nov 1992
Decision
364d
Days
-
Risk

K914970 is an FDA 510(k) clearance for the CARDIOVIT CS-100.

Submitted by Schiller America, Inc. (Tustin, US). The FDA issued a Cleared decision on November 3, 1992 after a review of 364 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K914970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date November 03, 1992
Days to Decision 364 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 125d · This submission: 364d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -