Cleared Traditional

K941254 - DYE MANAGEMENT SYSTEM

K941254 is an FDA 510(k) clearance for DYE MANAGEMENT SYSTEM, manufactured by Abbott Laboratories. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K941254 · Abbott Laboratories · Cardiovascular device
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Jun 1994
Decision
94d
Days
Class 2
Risk

K941254 is an FDA 510(k) clearance for the DYE MANAGEMENT SYSTEM. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K941254

510(k) Number K941254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1994
Decision Date June 13, 1994
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 319
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K941254.
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TRANSIT INFUSION CATHETER
K936260 · Cordis Corp. · May 1994
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
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SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
K934581 · Scimed Life Systems, Inc. · Mar 1994