Cleared Traditional

K900843 - OXIMAX 100

K900843 is an FDA 510(k) clearance for OXIMAX 100, manufactured by Pace Tech, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K900843 · Pace Tech, Inc. · Anesthesiology device
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Mar 1990
Decision
34d
Days
Class 2
Risk

K900843 is an FDA 510(k) clearance for the OXIMAX 100. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 28, 1990 after a review of 34 days - a notably fast clearance cycle.

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: 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 Pace Tech, Inc. devices

FDA 510(k) Submission Details - K900843

510(k) Number K900843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1990
Decision Date March 28, 1990
Days to Decision 34 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
106d faster than avg
Panel avg: 140d · This submission: 34d
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 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K900843.
MODEL 90489 PULSE OXIMETER MODULE
K901209 · Spacelabs, Inc. · Apr 1990
VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE
K901612 · Pace Tech, Inc. · Apr 1990
OXIMAX 700
K900866 · Pace Tech, Inc. · Apr 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · Nonin Medical, Inc. · Feb 1990
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
K893643 · Novametrix Medical Systems, Inc. · Oct 1989
ESCORT PULSE OXIMETRY OPTION
K892120 · Medical Data Electronics · Sep 1989