Cleared Traditional

K952531 - QUEST VEIN GRAFT PERFUSION SET

K952531 is the FDA 510(k) clearance for QUEST VEIN GRAFT PERFUSION SET by Quest Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K952531 · Quest Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
84d
Days
Class 2
Risk

K952531 is an FDA 510(k) clearance for the QUEST VEIN GRAFT PERFUSION SET. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Quest Medical, Inc. devices

Submission Details

510(k) Number K952531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1995
Decision Date August 24, 1995
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 65
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K952531.
ADAPTERS WITH X-COATING
K003604 · Terumo Cardiovascular Systems Corp. · Feb 2001
MBA
K993057 · Merit Medical Systems, Inc. · Oct 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · Guidant Corp. · Jun 1999
BRAUN MANIFOLD
K942391 · B.Braun Medical, Inc. · Jun 1995
SCIMED GATEWAY PLUS
K951089 · Scimed Life Systems, Inc. · May 1995
CHECK VALVE (FITTING)
K933084 · Merit Medical Systems, Inc. · Mar 1994