Cleared Traditional

K841958 - CARDIO METRICS CARDIOTOMY RESERVOIR

K841958 is an FDA 510(k) clearance for CARDIO METRICS CARDIOTOMY RESERVOIR, manufactured by Sterile Design, Inc.. The device is a Class 2 Cardiovascular device with product code JOD cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K841958

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.

JOD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

All 11
Devices cleared under the same product code (JOD) and FDA review panel - the closest regulatory comparables to K841958.
PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
K875095 · Pall Biomedical Products Co. · Feb 1988
PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
K874405 · Pall Biomedical Products Co. · Dec 1987
SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100
K855067 · Cobe Laboratories, Inc. · Feb 1986
CARDIOTOMY FILTER
K830634 · Texas Medical Products, Inc. · Jun 1983
INTERFACE CARDIOTOMY BLOOD FILTER #50
K823259 · Medical, Inc. · Nov 1982
INTERFACE CARDIOTOMY BLOOD FILTER #51
K823260 · Medical, Inc. · Nov 1982