Cleared Traditional

K910950 - HMS-4000 MULTICHANNEL PHYSIO MONIT SYST

K910950 is the FDA 510(k) clearance for HMS-4000 MULTICHANNEL PHYSIO MONIT SYST by Vitalog Monitoring,Inc.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K910950 · Vitalog Monitoring,Inc. · Anesthesiology device
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Aug 1991
Decision
157d
Days
Class 2
Risk

K910950 is an FDA 510(k) clearance for the HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalog Monitoring,Inc. (Redwood, US). The FDA issued a Cleared decision on August 2, 1991 after a review of 157 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 K910950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1991
Decision Date August 02, 1991
Days to Decision 157 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 140d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 30
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