Cleared Traditional

K941492 - PRESSURE RELIEF VALVE

K941492 is an FDA 510(k) clearance for PRESSURE RELIEF VALVE, manufactured by Circulatory Technology, Inc.. The device is a Class 2 Cardiovascular device with product code MNJ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K941492 · Circulatory Technology, Inc. · Cardiovascular device
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Oct 1994
Decision
212d
Days
Class 2
Risk

K941492 is an FDA 510(k) clearance for the PRESSURE RELIEF VALVE. Classified as Valve, Pressure Relief, Cardiopulmonary Bypass (product code MNJ), Class II - Special Controls.

Submitted by Circulatory Technology, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on October 26, 1994 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Circulatory Technology, Inc. devices

FDA 510(k) Submission Details - K941492

510(k) Number K941492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1994
Decision Date October 26, 1994
Days to Decision 212 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
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNJ Device Classification - Class 2, Special Controls

Product Code MNJ Valve, Pressure Relief, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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.