Cleared Traditional

K935510 - VX4 RECORDING PULSE OXIMETER

K935510 is the FDA 510(k) clearance for VX4 RECORDING PULSE OXIMETER by Vitalog Monitoring,Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 K935510.
MARQUETTE ADULT/NEONATAL WRAP SENSOR
K943817 · Marquette Electronics, Inc. · Oct 1994
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994
OXISAT
K934091 · Marquette Electronics, Inc. · Mar 1994
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992