Cleared Traditional

CARDIO METRICS CARDIOTOMY RESERVOIR (K841958) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841958 · Sterile Design, Inc. · Cardiovascular device
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Oct 1984
Decision
154d
Days
Class 2
Risk

K841958 is an FDA 510(k) clearance for the CARDIO METRICS CARDIOTOMY RESERVOIR. Classified as Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (product code JOD), Class II - Special Controls.

Submitted by Sterile Design, Inc. (Oldsmar, US). The FDA issued a Cleared decision on October 15, 1984 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4270 - 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 Sterile Design, Inc. devices

Submission Details

510(k) Number K841958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date October 15, 1984
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4270
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.