Cleared Traditional

K925049 - QUEST HEART INSULATION PAD

K925049 is the FDA 510(k) clearance for QUEST HEART INSULATION PAD by Quest Medical, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 483-day FDA review.

K925049 · Quest Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
483d
Days
Class 2
Risk

K925049 is an FDA 510(k) clearance for the QUEST HEART INSULATION PAD. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Dallas, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Quest Medical, Inc. devices

Submission Details

510(k) Number K925049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1992
Decision Date February 01, 1994
Days to Decision 483 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
358d slower than avg
Panel avg: 125d · This submission: 483d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 229
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K925049.
QUEST CORONARY SINUS PERFUSION CANNULA
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SARNS RETROGRADE CANNULA
K925442 · 3M Health Care, Sarns · May 1993
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K920902 · 3M Health Care, Sarns · May 1993
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K930684 · C.R. Bard, Inc. · May 1993