Cleared Traditional

CAPIOX HARDSHELL VENOUS RESERVOIR (K894664) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894664 · Terumo Medical Corp. · Cardiovascular device
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Apr 1990
Decision
270d
Days
Class 2
Risk

K894664 is an FDA 510(k) clearance for the CAPIOX HARDSHELL VENOUS RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on April 20, 1990 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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

Submission Details

510(k) Number K894664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date April 20, 1990
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 53
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K894664.
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · Shiley, Inc. · Aug 1991
INTERSEPT 1375 VENOUS RESERVOIR
K903632 · Medtronic Vascular · Dec 1990
SOFTSHELL VENOUS RESERVOIR
K904040 · C.R. Bard, Inc. · Dec 1990
UNIVOX-IC
K895356 · Baxter Healthcare Corp · Mar 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K893711 · Shiley, Inc. · Feb 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414 · Baxter Healthcare Corp · Jan 1990