Cleared Traditional

K943861 - CAPIOX SP PUMP HEAD

K943861 is an FDA 510(k) clearance for CAPIOX SP PUMP HEAD, manufactured by Terumo Corp.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K943861 · Terumo Corp. · Cardiovascular device
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Aug 1995
Decision
372d
Days
Class 2
Risk

K943861 is an FDA 510(k) clearance for the CAPIOX SP PUMP HEAD. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Corp. devices

FDA 510(k) Submission Details - K943861

510(k) Number K943861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1994
Decision Date August 15, 1995
Days to Decision 372 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
247d slower than avg
Panel avg: 125d · This submission: 372d
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 66
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K943861.
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
K972740 · Himex Production Corp. · Feb 1998
CAPIOX SP PUMP HEAD
K962981 · Terumo Medical Corp. · Feb 1997
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · Baxter Healthcare Corp · Apr 1996
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
K933014 · St. Jude Medical, Inc. · Sep 1994
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
K915547 · 3M Health Care, Sarns · Sep 1993
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
K915363 · 3M Health Care, Ltd. · Jul 1993