Cleared Traditional

K960074 - CAPIOX SX10 HOLLOW FIBER OXYGENATOR WIT...

K960074 is an FDA 510(k) clearance for CAPIOX SX10 HOLLOW FIBER OXYGENATOR WIT..., 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 279-day FDA review.

K960074 · Terumo Medical Corp. · Cardiovascular device
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Oct 1996
Decision
279d
Days
Class 2
Risk

K960074 is an FDA 510(k) clearance for the CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR. 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 October 16, 1996 after a review of 279 days - an extended review 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: 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 - K960074

510(k) Number K960074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date October 16, 1996
Days to Decision 279 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
154d slower than avg
Panel avg: 125d · This submission: 279d
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 K960074.
MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER
K962641 · Medtronic Vascular · Dec 1996
GISH RELIANCE OXYGENATOR (MODEL HFO)
K961530 · Gish Biomedical, Inc. · Dec 1996
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
K954850 · C.R. Bard, Inc. · Oct 1996
CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
K962667 · Terumo Medical Corp. · Oct 1996
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
K961000 · Terumo Medical Corp. · Oct 1996
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
K951247 · Baxter Healthcare Corp · Nov 1995