Cleared Traditional

K952184 - CARBOMEDICS SUPRA-ANNULAR VALVE SIZER

K952184 is an FDA 510(k) clearance for CARBOMEDICS SUPRA-ANNULAR VALVE SIZER, manufactured by Carbomedics, Inc.. The device is a Class 1 Cardiovascular device with product code DTI cleared through the Traditional 510(k) pathway after a 204-day FDA review.

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

FDA 510(k) Submission Details - K952184

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

DTI Device Classification - Class 1, General Controls

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.