Cleared Traditional

K052555 - MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB

K052555 is an FDA 510(k) clearance for MEDTRONIC PERFORMER TM CPB, manufactured by Rand S.R.L.. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K052555 · Rand S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
180d
Days
Class 2
Risk

K052555 is an FDA 510(k) clearance for the MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Rand S.R.L. (Minneapolis, US). The FDA issued a Cleared decision on March 15, 2006 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Rand S.R.L. devices

FDA 510(k) Submission Details - K052555

510(k) Number K052555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date March 15, 2006
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 40
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K052555.
PERFORMER CBP SYSTEM
K070213 · Rand S.R.L. · Mar 2007
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STOCKERT S5 SYSTEM
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ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
STOCKERT COMPACT SYSTEM
K982014 · Stoeckert Instrumente · Sep 1998
AFFINITY BLOOD PUMP SYSTEM
K964017 · Avecor Cardiovascular, Inc. · Aug 1997