Cleared Traditional

K962981 - CAPIOX SP PUMP HEAD

K962981 is an FDA 510(k) clearance for CAPIOX SP PUMP HEAD, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K962981 · Terumo Medical Corp. · Cardiovascular device
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Feb 1997
Decision
208d
Days
Class 2
Risk

K962981 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 Medical Corp. (Elkton, US). The FDA issued a Cleared decision on February 25, 1997 after a review of 208 days - an extended review 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: 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 Medical Corp. devices

FDA 510(k) Submission Details - K962981

510(k) Number K962981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1996
Decision Date February 25, 1997
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
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 46
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K962981.
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp. · Apr 2002
COBE REVOLUTION
K011835 · Cobe Cardiovascular, Inc. · Feb 2002
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · Terumo Cardiovascular Systems Corp. · Aug 2001
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