Cleared Traditional

K952184 - CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (FDA 510(k) Clearance)

Class I Cardiovascular device.

K952184 · Carbomedics, Inc. · Cardiovascular device
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Nov 1995
Decision
204d
Days
Class 1
Risk

K952184 is an FDA 510(k) clearance for the CARBOMEDICS SUPRA-ANNULAR VALVE SIZER. Classified as Sizer, Heart-valve, Prosthesis (product code DTI), Class I - General Controls.

Submitted by Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 204 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3945 - 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 Carbomedics, Inc. devices

Submission Details

510(k) Number K952184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date November 29, 1995
Days to Decision 204 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
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTI Sizer, Heart-valve, Prosthesis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3945
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.