Cleared Traditional

K926233 - CARDIO2 CYCLE

K926233 is an FDA 510(k) clearance for CARDIO2 CYCLE, manufactured by Ergometrix, Inc.. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K926233 · Ergometrix, Inc. · Cardiovascular device
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Jun 1993
Decision
175d
Days
Class 1
Risk

K926233 is an FDA 510(k) clearance for the CARDIO2 CYCLE. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Ergometrix, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 4, 1993 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - the FDA cardiovascular device oversight framework. 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ergometrix, Inc. devices

FDA 510(k) Submission Details - K926233

510(k) Number K926233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1992
Decision Date June 04, 1993
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

KRI Device Classification - Class 1, General Controls

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

All 33
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K926233.
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