Cleared Traditional

CARDIO PERFECT, CARDIO PERFECT MD (K922898) - FDA 510(k) Clearance

K922898 · Cardio Control BV · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 15
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K922898.
ECG FAX MODEM
K941282 · Hewlett-Packard Co. · May 1995
HP M177XA CARDIOGRAPHS
K935772 · Hewlett-Packard Co. · Jul 1994
CARDIOFAX Q ECG-8420A
K922394 · Nihon Kohden America, Inc. · Mar 1994
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · Hewlett-Packard Co. · Jul 1990
Q750 ELECTROCARDIOGRAPH
K885000 · Quinton, Inc. · Feb 1989
MINGOGRAF 740 - MODEL #91-54-634
K864575 · Siemens Medical Solutions USA, Inc. · May 1987