Cleared Traditional

K803231 - THB 6000 HARDSHELL BUBBLE OXYGENATOR

K803231 is the FDA 510(k) clearance for THB 6000 HARDSHELL BUBBLE OXYGENATOR by Travenol Laboratories, S.A.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K803231 · Travenol Laboratories, S.A. · Cardiovascular device
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Jan 1981
Decision
25d
Days
Class 2
Risk

K803231 is an FDA 510(k) clearance for the THB 6000 HARDSHELL BUBBLE OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 25 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K803231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1980
Decision Date January 16, 1981
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 191
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K803231.
CARDIOPULMONARY BYPASS OXYGENATOR
K810505 · Cobe Laboratories, Inc. · Apr 1981
SHILEY S-100A (ADULT) BLOOD OXYGENATOR
K810470 · Shiley, Inc. · Apr 1981
INTERPULSE MEMBRANE OXYGENATION SYSTEM
K803003 · Extracorporeal Medical Specialities, Inc. · Jan 1981
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S
K802719 · Bentley Laboratories, Inc. · Dec 1980
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S
K802720 · Bentley Laboratories, Inc. · Dec 1980
BUILT-IN TEMPERATURE MONITORING
K801240 · Bentley Laboratories, Inc. · Jun 1980