Cleared Traditional

K031700 - MEDTRONIC RESTING HEART SYSTEM

K031700 is an FDA 510(k) clearance for MEDTRONIC RESTING HEART SYSTEM, manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K031700 · Medtronic Perfusion Systems · Cardiovascular device
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Aug 2003
Decision
88d
Days
Class 2
Risk

K031700 is an FDA 510(k) clearance for the MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 88 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 Medtronic Perfusion Systems devices

FDA 510(k) Submission Details - K031700

510(k) Number K031700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date August 29, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

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 133
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K031700.
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · Terumo Cardiovascular Systems Corp. · Mar 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800 · Terumo Cardiovascular Systems Corporation · Feb 2004
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · Cobe Cardiovascular, Inc. · Dec 2003
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · Gish Biomedical, Inc. · May 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · Gish Biomedical, Inc. · Mar 2003
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K021287 · Medtronic Perfusion Systems · May 2002