Cleared Traditional

K921500 - CENTRI-SAFE(TM) VALVE

K921500 is an FDA 510(k) clearance for CENTRI-SAFE(TM) VALVE, manufactured by Cardio Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MJJ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K921500 · Cardio Systems, Inc. · Cardiovascular device
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Sep 1992
Decision
168d
Days
Class 2
Risk

K921500 is an FDA 510(k) clearance for the CENTRI-SAFE(TM) VALVE. Classified as Cpb Check Valve, Retrograde Flow, In-line (product code MJJ), Class II - Special Controls.

Submitted by Cardio Systems, Inc. (Conshohocken, US). The FDA issued a Cleared decision on September 15, 1992 after a review of 168 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 Cardio Systems, Inc. devices

FDA 510(k) Submission Details - K921500

510(k) Number K921500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date September 15, 1992
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJJ Device Classification - Class 2, Special Controls

Product Code MJJ Cpb Check Valve, Retrograde Flow, In-line
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.