Cleared Traditional

K851613 - CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER

K851613 is an FDA 510(k) clearance for CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER, manufactured by Centrimed Corp.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K851613 · Centrimed Corp. · Cardiovascular device
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Jun 1985
Decision
61d
Days
Class 2
Risk

K851613 is an FDA 510(k) clearance for the CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Centrimed Corp. (Hopkins, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 61 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 Centrimed Corp. devices

FDA 510(k) Submission Details - K851613

510(k) Number K851613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1985
Decision Date June 19, 1985
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
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 60
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K851613.
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
K884659 · 3M Health Care, Sarns · Jan 1989
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
K882758 · 3M Health Care, Sarns · Oct 1988
ELECATH PULSATILE PERFUSION PUMP
K854975 · Electro-Catheter Corp. · Jan 1986
MODEL 1861 BLOOD PUMP
K780953 · Medtronic Vascular · Aug 1978