Cleared Traditional

K002496 - MODEL 4815 ADAPTER

K002496 is the FDA 510(k) clearance for MODEL 4815 ADAPTER by Pace Medical. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K002496 · Pace Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
57d
Days
Class 2
Risk

K002496 is an FDA 510(k) clearance for the MODEL 4815 ADAPTER. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on October 10, 2000 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Pace Medical devices

Submission Details

510(k) Number K002496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2000
Decision Date October 10, 2000
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 127
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K002496.
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · Gish Biomedical, Inc. · Mar 2003
CAPIOX RX HARDSHELL RESERVOIR
K013526 · Terumo Cardiovascular Systems Corp. · Nov 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · Medtronic Vascular · Jul 2001
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · Terumo Cardiovascular Systems Corp. · Aug 2000
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389 · Cobe Cardiovascular, Inc. · Mar 2000
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
K993001 · Cobe Cardiovascular, Inc. · Dec 1999