Cleared Traditional

K112229 - SARN CENTRIFUGAL PUMP

K112229 is an FDA 510(k) clearance for SARN CENTRIFUGAL PUMP, manufactured by Terumo Cardiovascular Systems. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K112229 · Terumo Cardiovascular Systems · Cardiovascular device
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Dec 2011
Decision
128d
Days
Class 2
Risk

K112229 is an FDA 510(k) clearance for the SARN CENTRIFUGAL PUMP. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems (Ann Arbor, US). The FDA issued a Cleared decision on December 9, 2011 after a review of 128 days - within the typical 510(k) review window.

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: 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 Terumo Cardiovascular Systems devices

FDA 510(k) Submission Details - K112229

510(k) Number K112229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2011
Decision Date December 09, 2011
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFM Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K112229.
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
K170029 · International Biophysics Corporation · Dec 2017
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
K132712 · Medtronic, Inc. · Nov 2013
QUADROX-IR ADULT AND SMALL ADULT
K133265 · Maquet Cardiopulmonary, AG · Nov 2013
TANDEMHEART PUMP
K110493 · Cardiacassist, Inc. · Sep 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
K111972 · Medtronic, Inc. · Jul 2011
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · Medtronic, Inc. · Jun 2011