Cleared Traditional

K943861 - CAPIOX SP PUMP HEAD

K943861 is the FDA 510(k) clearance for CAPIOX SP PUMP HEAD by Terumo Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

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 42
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K943861.
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · Terumo Cardiovascular Systems Corp. · Aug 2001
CAPIOX SP PUMP HEAD
K962981 · Terumo Medical Corp. · Feb 1997
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · Baxter Healthcare Corp · Apr 1996
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
DELPHIN II CENTRIFUGAL SYSTEM
K913176 · 3M Health Care, Sarns · Nov 1991