Cleared Traditional

K915265 - CDI(TM) H/S CUVETTE

K915265 is the FDA 510(k) clearance for CDI(TM) H/S CUVETTE by 3M Company. It is a Class 2 Cardiovascular device (product code DRY) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K915265 · 3M Company · Cardiovascular device
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Jan 1992
Decision
57d
Days
Class 2
Risk

K915265 is an FDA 510(k) clearance for the CDI(TM) H/S CUVETTE, MODIFICATION. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by 3M Company (Tustin, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 57 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 Company devices

Submission Details

510(k) Number K915265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date January 15, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
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 K915265.
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962 · 3M Company · Nov 1997
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
K931968 · 3M Health Care, Ltd. · Nov 1993
CDI(TM) 300, 400 & 100, MODIFICATION
K915255 · 3M Company · Jan 1992
SATURATION/HEMATOCRIT MONITOR SYSTEM
K910421 · Medtronic Vascular · Oct 1991
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
K881006 · Shiley, Inc. · May 1988
STAT-SAT
K874839 · Gish Biomedical, Inc. · May 1988