Cleared Traditional

K823125 - CAPIOX II

K823125 is an FDA 510(k) clearance for CAPIOX II, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K823125 · Terumo Medical Corp. · Cardiovascular device
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Nov 1982
Decision
30d
Days
Class 2
Risk

K823125 is an FDA 510(k) clearance for the CAPIOX II. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on November 24, 1982 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K823125

510(k) Number K823125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 24, 1982
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K823125.
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
K823273 · Bentley Laboratories, Inc. · Jan 1983
OXYGENATORS #BOS-10, 105, 5S
K823456 · Bentley Laboratories, Inc. · Dec 1982
OXYGENATOR 10
K823343 · Gambro, Inc. · Dec 1982
WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD
K821477 · C.R. Bard, Inc. · Nov 1982
BLOOD OXYGENATORS #BOS-105S BOS-5S W/
K822803 · Bentley Laboratories, Inc. · Nov 1982
INTERPULSE MEMBRANE OXYGENATOR
K821216 · Extracorporeal Medical Specialities, Inc. · Jun 1982