Cleared Traditional

K914620 - HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION

K914620 is an FDA 510(k) clearance for HMS-4000 PHYSIOLOGICAL MONITOR, 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 198-day FDA review.

K914620 · Vitalog Monitoring,Inc. · Anesthesiology device
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May 1992
Decision
198d
Days
Class 2
Risk

K914620 is an FDA 510(k) clearance for the HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Vitalog Monitoring,Inc. (Redwood, US). The FDA issued a Cleared decision on May 1, 1992 after a review of 198 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 - K914620

510(k) Number K914620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1991
Decision Date May 01, 1992
Days to Decision 198 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
58d slower than avg
Panel avg: 140d · This submission: 198d
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 K914620.
BIOCHEM MODEL 3301 NEWOX1 OXIMETER
K920082 · Biochem International, Inc. · Jan 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
K920379 · Novametrix Medical Systems, Inc. · Jul 1992
SENSORMEDICS OXYSHUTTLE II(TM)
K913790 · Sensor Medics Corp. · Feb 1992
VITALMAX 510/520
K912880 · Pace Tech, Inc. · Nov 1991
NELLCOR(R) N-180 PULSE OXIMETER
K913695 · Nellcor, Inc. · Nov 1991