Cleared Traditional

K902654 - CDI (TM) SYSTEM 100 MONITORING SYSTEM

K902654 is an FDA 510(k) clearance for CDI (TM) SYSTEM 100 MONITORING SYSTEM, manufactured by 3M Health Care, Ltd.. The device is a Class 2 Cardiovascular device with product code DTY cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K902654 · 3M Health Care, Ltd. · Cardiovascular device
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Nov 1990
Decision
143d
Days
Class 2
Risk

K902654 is an FDA 510(k) clearance for the CDI (TM) SYSTEM 100 MONITORING SYSTEM. Classified as Sensor, Blood-gas, In-line, Cardiopulmonary Bypass (product code DTY), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (Irvine, US). The FDA issued a Cleared decision on November 5, 1990 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4410 - 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

FDA 510(k) Submission Details - K902654

510(k) Number K902654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1990
Decision Date November 05, 1990
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTY Device Classification - Class 2, Special Controls

Product Code DTY Sensor, Blood-gas, In-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4410
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.