Cleared Traditional

K901071 - PULSE OXIMETRY MODULE

K901071 is an FDA 510(k) clearance for PULSE OXIMETRY MODULE, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K901071 · Marquette Electronics, Inc. · Anesthesiology device
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Jun 1990
Decision
104d
Days
Class 2
Risk

K901071 is an FDA 510(k) clearance for the PULSE OXIMETRY MODULE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 19, 1990 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K901071

510(k) Number K901071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date June 19, 1990
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 628
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K901071.
TYPE 9293 INTERFACE PULSEOX
K896738 · S & W Medico Teknik · Aug 1990
ITC ANGIOGRAPHIC CATHETER
K900757 · Interventional Therapeutics Corp. · Aug 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · Hewlett-Packard Co. · Jul 1990
POWERBASE II (PB2)
K901399 · Nellcor, Inc. · Jun 1990
ESCORT MODEL 300
K902060 · Medical Data Electronics · Jun 1990
HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
K901774 · Mennen Medical, Inc. · May 1990