Cleared Traditional

K922898 - CARDIO PERFECT, CARDIO PERFECT MD

K922898 · Cardio Control BV · Cardiovascular device
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Nov 1993
Decision
503d
Days
-
Risk

K922898 is an FDA 510(k) clearance for the CARDIO PERFECT, CARDIO PERFECT MD.

Submitted by Cardio Control BV (The Netherlands, NL). The FDA issued a Cleared decision on November 1, 1993 after a review of 503 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.

View all Cardio Control BV devices

FDA 510(k) Submission Details - K922898

510(k) Number K922898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1992
Decision Date November 01, 1993
Days to Decision 503 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
378d slower than avg
Panel avg: 125d · This submission: 503d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 60
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