Cleared Traditional

K961000 - CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR

K961000 is an FDA 510(k) clearance for CAPIOX SX18 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 204-day FDA review.

K961000 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
204d
Days
Class 2
Risk

K961000 is an FDA 510(k) clearance for the CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RES.... 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 2, 1996 after a review of 204 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 - K961000

510(k) Number K961000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1996
Decision Date October 02, 1996
Days to Decision 204 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
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 241
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K961000.
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
K954850 · C.R. Bard, Inc. · Oct 1996
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR
K960074 · Terumo Medical Corp. · Oct 1996
CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
K962667 · Terumo Medical Corp. · Oct 1996
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
K953835 · Dideco S.R.L. · Mar 1996
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
K951247 · Baxter Healthcare Corp · Nov 1995
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K941473 · Medtronic Vascular · Jun 1995