Cleared Traditional

K802328 - DISP. TOUGY-BORST TYPE ADAPTOR W/PORT

K802328 is an FDA 510(k) clearance for DISP. TOUGY-BORST TYPE ADAPTOR W/PORT, manufactured by Stanco Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K802328 · Stanco Medical, Inc. · Cardiovascular device
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Oct 1980
Decision
17d
Days
Class 2
Risk

K802328 is an FDA 510(k) clearance for the DISP. TOUGY-BORST TYPE ADAPTOR W/PORT. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Stanco Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 17 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 Stanco Medical, Inc. devices

FDA 510(k) Submission Details - K802328

510(k) Number K802328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date October 10, 1980
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 222
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K802328.
THB 6000 HARDSHELL BUBBLE OXYGENATOR
K803231 · Travenol Laboratories, S.A. · 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
DELTA D-750 THERMAFLOW
K790406 · Delta Medical Industries · Nov 1979
WILLIAM HARVEY H-1500 BLOOD OXYGENATOR
K792039 · C.R. Bard, Inc. · Oct 1979