Cleared Traditional

K790406 - DELTA D-750 THERMAFLOW

K790406 is an FDA 510(k) clearance for DELTA D-750 THERMAFLOW, manufactured by Delta Medical Industries. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K790406

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
Combination Product No
PCCP Authorized No
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.

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 235
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K790406.
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S
K802720 · Bentley Laboratories, Inc. · Dec 1980
DISP. TOUGY-BORST TYPE ADAPTOR W/PORT
K802328 · Stanco Medical, Inc. · Oct 1980
BUILT-IN TEMPERATURE MONITORING
K801240 · Bentley Laboratories, Inc. · Jun 1980
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 BOS-10
K781842 · Bentley Laboratories, Inc. · Nov 1978