Cleared Traditional

K935510 - VX4 RECORDING PULSE OXIMETER

K935510 is an FDA 510(k) clearance for VX4 RECORDING PULSE OXIMETER, manufactured by Vitalog Monitoring,Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K935510 · Vitalog Monitoring,Inc. · Anesthesiology device
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Jul 1994
Decision
227d
Days
Class 2
Risk

K935510 is an FDA 510(k) clearance for the VX4 RECORDING PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Vitalog Monitoring,Inc. (Redwood, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 227 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 Vitalog Monitoring,Inc. devices

FDA 510(k) Submission Details - K935510

510(k) Number K935510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date July 01, 1994
Days to Decision 227 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 140d · This submission: 227d
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 681
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K935510.
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PULSE OXIMETER
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K921454 · Fukuda Denshi USA, Inc. · Apr 1994