Cleared Traditional

K931968 - CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGE...

K931968 is the FDA 510(k) clearance for CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGE... by 3M Health Care, Ltd.. It is a Class 2 Cardiovascular device (product code DRY) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K931968 · 3M Health Care, Ltd. · Cardiovascular device
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Nov 1993
Decision
203d
Days
Class 2
Risk

K931968 is an FDA 510(k) clearance for the CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (Tustin, US). The FDA issued a Cleared decision on November 10, 1993 after a review of 203 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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 3M Health Care, Ltd. devices

Submission Details

510(k) Number K931968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1993
Decision Date November 10, 1993
Days to Decision 203 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 125d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 20
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K931968.
CDI BLOOD PARAMETER MONITORING SYSTEM 500
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3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962 · 3M Company · Nov 1997
CDI(TM) 300, 400 & 100, MODIFICATION
K915255 · 3M Company · Jan 1992
CDI(TM) H/S CUVETTE, MODIFICATION
K915265 · 3M Company · Jan 1992
SATURATION/HEMATOCRIT MONITOR SYSTEM
K910421 · Medtronic Vascular · Oct 1991