Cleared Traditional

K061072 - ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE...

K061072 is the FDA 510(k) clearance for ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K061072 · Maquet Cardiopulmonary, AG · Cardiovascular device
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May 2006
Decision
36d
Days
Class 2
Risk

K061072 is an FDA 510(k) clearance for the ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on May 23, 2006 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K061072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date May 23, 2006
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 41
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K061072.
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · Terumo Cardiovascular Systems Corp. · Feb 2009
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470 · Maquet Cardiopulmonary, AG · Sep 2008
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
K080774 · Terumo Cardiovascular Systems Corp. · Apr 2008
IBC FLOPUMP WITH GBS COATING
K031300 · Gish Biomedical, Inc. · May 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · Cobe Cardiovascular, Inc. · Mar 2003
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp. · Apr 2002