Cleared Traditional

K790406 - DELTA D-750 THERMAFLOW

K790406 is the FDA 510(k) clearance for DELTA D-750 THERMAFLOW by Delta Medical Industries. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K790406 · Delta Medical Industries · Cardiovascular device
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Nov 1979
Decision
260d
Days
Class 2
Risk

K790406 is an FDA 510(k) clearance for the DELTA D-750 THERMAFLOW. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Delta Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 260 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 Delta Medical Industries devices

Submission Details

510(k) Number K790406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date November 13, 1979
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 125d · This submission: 260d
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 124
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K790406.
SHILEY S-100A (ADULT) BLOOD OXYGENATOR
K810470 · Shiley, Inc. · Apr 1981
INTERPULSE MEMBRANE OXYGENATION SYSTEM
K803003 · Extracorporeal Medical Specialities, Inc. · Jan 1981
THB 6000 HARDSHELL BUBBLE OXYGENATOR
K803231 · Travenol Laboratories, S.A. · Jan 1981
WILLIAM HARVEY H-1500 BLOOD OXYGENATOR
K792039 · C.R. Bard, Inc. · Oct 1979
OXYGENATOR, COBE CATALOG #42-220
K790356 · Cobe Laboratories, Inc. · Mar 1979
OXYGENATOR, BLOOD, INFANT/PEDIATRIC
K781223 · Shiley, Inc. · Jul 1978