Cleared Traditional

K901612 - VITALMAX 2000 ECG MONITOR W/NON-INVASIV...

K901612 is the FDA 510(k) clearance for VITALMAX 2000 ECG MONITOR W/NON-INVASIV... by Pace Tech, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K901612 · Pace Tech, Inc. · Anesthesiology device
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Apr 1990
Decision
24d
Days
Class 2
Risk

K901612 is an FDA 510(k) clearance for the VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Pace Tech, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 30, 1990 after a review of 24 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

Submission Details

510(k) Number K901612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1990
Decision Date April 30, 1990
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K901612.
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
K902758 · Cobe Laboratories, Inc. · Aug 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · Hewlett-Packard Co. · Jul 1990
PULSE OXIMETRY MODULE
K901071 · Marquette Electronics, Inc. · Jun 1990
CNS-8200A CENTRAL NURSES STATION
K884050 · Nihon Kohden America, Inc. · Feb 1989
AL-800PA PULSE OXIMETER MODULE
K884536 · Nihon Kohden America, Inc. · Feb 1989
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
K884329 · Baxter Healthcare Corp · Dec 1988