Cleared Traditional

K901736 - OXIMETRY PROBE CATHETERS

K901736 is an FDA 510(k) clearance for OXIMETRY PROBE CATHETERS, manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DQE cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K901736 · Baxter Healthcare Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
147d
Days
Class 2
Risk

K901736 is an FDA 510(k) clearance for the OXIMETRY PROBE CATHETERS. Classified as Catheter, Oximeter, Fiber-optic (product code DQE), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 11, 1990 after a review of 147 days - within the typical 510(k) review window.

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: 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K901736

510(k) Number K901736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date September 11, 1990
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQE Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (DQE) and FDA review panel - the closest regulatory comparables to K901736.
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450 · Baxter Healthcare Corp · Feb 1993
MARQUETTE SV O2 MODULE
K915073 · Marquette Electronics, Inc. · Dec 1992
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
K905458 · Baxter Healthcare Corp · Feb 1991
POET OXIMETER
K864745 · Criticare Systems, Inc. · Jun 1987