Cleared Traditional

K901612 - VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE

K901612 is an FDA 510(k) clearance for VITALMAX 2000 ECG MONITOR W/NON-INVASIV..., 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 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

FDA 510(k) Submission Details - K901612

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
Combination Product No
PCCP Authorized No
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.

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 K901612.
EDENTEC MODEL 2000W SYSTEM 700 MONITOR
K901060 · Edentec Corp. · May 1990
OXYTRAK(TM) PULSE OXIMETER
K894100 · Critikon Company, LLC · May 1990
MODEL 90489 PULSE OXIMETER MODULE
K901209 · Spacelabs, Inc. · Apr 1990
OXIMAX 700
K900866 · Pace Tech, Inc. · Apr 1990
OXIMAX 100
K900843 · Pace Tech, Inc. · Mar 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · Nonin Medical, Inc. · Feb 1990