Cleared Traditional

K915073 - MARQUETTE SV O2 MODULE

K915073 is the FDA 510(k) clearance for MARQUETTE SV O2 MODULE by Marquette Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DQE) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K915073 · Marquette Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
417d
Days
Class 2
Risk

K915073 is an FDA 510(k) clearance for the MARQUETTE SV O2 MODULE. Classified as Catheter, Oximeter, Fiber-optic (product code DQE), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 29, 1992 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1230 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K915073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date December 29, 1992
Days to Decision 417 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
292d slower than avg
Panel avg: 125d · This submission: 417d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQE Catheter, Oximeter, Fiber-optic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1230
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 - DQE Catheter, Oximeter, Fiber-optic

All 14
Devices cleared under the same product code (DQE) and FDA review panel - the closest regulatory comparables to K915073.
PRESEP OLIGON OXIMETRY CATHETERS
K060093 · Edwards Lifesciences, LLC · Apr 2006
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K053609 · Edwards Lifesciences, LLC · Feb 2006
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450 · Baxter Healthcare Corp · Feb 1993
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
K905458 · Baxter Healthcare Corp · Feb 1991
OXIMETRY PROBE CATHETERS
K901736 · Baxter Healthcare Corp · Sep 1990