Cleared Traditional

K901066 - VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.

K901066 is an FDA 510(k) clearance for VITALMAX 500 PULSE OXIMETER W/TEMP. AND..., 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 174-day FDA review.

K901066 · Pace Tech, Inc. · Anesthesiology device
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Aug 1990
Decision
174d
Days
Class 2
Risk

K901066 is an FDA 510(k) clearance for the VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 28, 1990 after a review of 174 days - an extended review 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: 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 Pace Tech, Inc. devices

FDA 510(k) Submission Details - K901066

510(k) Number K901066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date August 28, 1990
Days to Decision 174 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
34d slower than avg
Panel avg: 140d · This submission: 174d
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 K901066.
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MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA
K902779 · S & W Medico Teknik · Sep 1990
MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.
K901504 · Ivy Biomedical Systems, Inc. · Aug 1990
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
K902758 · Cobe Laboratories, Inc. · Aug 1990
TYPE 9293 INTERFACE PULSEOX
K896738 · S & W Medico Teknik · Aug 1990