Cleared Traditional

K823343 - OXYGENATOR 10

K823343 is an FDA 510(k) clearance for OXYGENATOR 10, manufactured by Gambro, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K823343 · Gambro, Inc. · Cardiovascular device
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Dec 1982
Decision
37d
Days
Class 2
Risk

K823343 is an FDA 510(k) clearance for the OXYGENATOR 10. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 37 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K823343

510(k) Number K823343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1982
Decision Date December 15, 1982
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K823343.
DOSIMETRIC RELEASE OF RADIATION DEV
K830327 · American Bentley · Mar 1983
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
K823273 · Bentley Laboratories, Inc. · Jan 1983
OXYGENATORS #BOS-10, 105, 5S
K823456 · Bentley Laboratories, Inc. · Dec 1982
CAPIOX II
K823125 · Terumo Medical Corp. · Nov 1982
WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD
K821477 · C.R. Bard, Inc. · Nov 1982
BLOOD OXYGENATORS #BOS-105S BOS-5S W/
K822803 · Bentley Laboratories, Inc. · Nov 1982