Cleared Traditional

K914620 - HMS-4000 PHYSIOLOGICAL MONITOR

K914620 is the FDA 510(k) clearance for HMS-4000 PHYSIOLOGICAL MONITOR by Vitalog Monitoring,Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 K914620.
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
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991
COROMETRICS MODEL 556 NEONATAL MONITOR
K900001 · Ge Medical Systems Information Technologies · Nov 1990