Cleared Traditional

K973472 - 3M CDI H/S CUVETTES WITH HEPARON TREATMENT

K973472 is an FDA 510(k) clearance for 3M CDI H/S CUVETTES WITH HEPARON TREATMENT, manufactured by 3M Healthcare. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K973472 · 3M Healthcare · Cardiovascular device
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Dec 1997
Decision
87d
Days
Class 2
Risk

K973472 is an FDA 510(k) clearance for the 3M CDI H/S CUVETTES WITH HEPARON TREATMENT. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by 3M Healthcare (Tistin, US). The FDA issued a Cleared decision on December 8, 1997 after a review of 87 days - a notably fast clearance 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: 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 3M Healthcare devices

FDA 510(k) Submission Details - K973472

510(k) Number K973472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1997
Decision Date December 08, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRY Device Classification - Class 2, Special Controls

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 22
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K973472.
CDI BLOOD PARAMETER MONITORING SYSTEM 500
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K012743 · Medtronic Perfusion Systems · Sep 2001
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962 · 3M Company · Nov 1997
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
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K915255 · 3M Company · Jan 1992