Cleared Traditional

K895414 - MULTIMED (TM) PULMONARY FUNCTION TESTIN...

K895414 is the FDA 510(k) clearance for MULTIMED (TM) PULMONARY FUNCTION TESTIN... by Integrated Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K895414 · Integrated Medical Systems, Inc. · Anesthesiology device
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Feb 1990
Decision
164d
Days
Class 2
Risk

K895414 is an FDA 510(k) clearance for the MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Integrated Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on February 12, 1990 after a review of 164 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 Integrated Medical Systems, Inc. devices

Submission Details

510(k) Number K895414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date February 12, 1990
Days to Decision 164 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 140d · This submission: 164d
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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