Cleared Traditional

K895414 - MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM

K895414 is an FDA 510(k) clearance for MULTIMED (TM) PULMONARY FUNCTION TESTIN..., manufactured by Integrated Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K895414

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.

BZG Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K895414.
SPIRO ANALYZER MODEL ST 250
K901308 · Futuremed Div. of Future Impex Corp. · Jul 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · Fukuda Denshi USA, Inc. · Apr 1990
SPIROSCAN 4000
K896924 · Brentwood Instruments, Inc. · Mar 1990
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989