Cleared Traditional

K893392 - CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER

K893392 is an FDA 510(k) clearance for CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT CO..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K893392 · Baxter Healthcare Corp · Cardiovascular device
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Jun 1989
Decision
50d
Days
Class 2
Risk

K893392 is an FDA 510(k) clearance for the CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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.

FDA 510(k) Submission Details - K893392

510(k) Number K893392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date June 20, 1989
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 176
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K893392.
NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
K897004 · Advanced Technology Laboratories, Inc. · Mar 1990
SFA MODULE
K896528 · Life Sciences Manufacturing, Inc. · Jan 1990
SENSOCOR TM R-TEST 24OXL
K894234 · Sensocor · Aug 1989
TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
K884122 · S & W Medico Teknik · Apr 1989
PACH-PEN CALCULATOR
K884619 · Oculab, Inc. · Feb 1989
PREDICTOR II SIGNAL AVERAGING ECG
K883855 · Corazonix Corp. · Nov 1988
K893392 · CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
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