Cleared Traditional

K962154 - CARBOMEDICS HANDLE (FDA 510(k) Clearance)

Class I Cardiovascular device.

K962154 · Carbomedics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
84d
Days
Class 1
Risk

K962154 is an FDA 510(k) clearance for the CARBOMEDICS HANDLE. Classified as Holder, Heart-valve, Prosthesis (product code DTJ), Class I - General Controls.

Submitted by Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 27, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3935 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carbomedics, Inc. devices

Submission Details

510(k) Number K962154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1996
Decision Date August 27, 1996
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTJ Holder, Heart-valve, Prosthesis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3935
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.