Cleared Traditional

K992559 - HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010

K992559 is an FDA 510(k) clearance for HOLLOW FIBER MEMBRANE OYGENATOR QUADROX..., manufactured by Jostra Bentley. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K992559 · Jostra Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
52d
Days
Class 2
Risk

K992559 is an FDA 510(k) clearance for the HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Jostra Bentley (Newark, US). The FDA issued a Cleared decision on September 20, 1999 after a review of 52 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 Jostra Bentley devices

FDA 510(k) Submission Details - K992559

510(k) Number K992559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1999
Decision Date September 20, 1999
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 226
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K992559.
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
K991737 · Dideco S.P.A. · Feb 2000
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
K990103 · Sorin Biomedical, Inc. · Nov 1999
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
K991452 · Cobe Cardiovascular, Inc. · Oct 1999
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
K992910 · Medtronic Vascular · Sep 1999
MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
K984271 · Medtronic Vascular · Mar 1999
COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
K974812 · Cobe Cardiovascular, Inc. · Jun 1998