Cleared Traditional

K903674 - MODEL 295 ELECTRONIC RESPIROMETER

K903674 is the FDA 510(k) clearance for MODEL 295 ELECTRONIC RESPIROMETER by National Medical Sales, Inc.. It is a Class 2 Anesthesiology device (product code BZK) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K903674 · National Medical Sales, Inc. · Anesthesiology device
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Jan 1991
Decision
144d
Days
Class 2
Risk

K903674 is an FDA 510(k) clearance for the MODEL 295 ELECTRONIC RESPIROMETER. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by National Medical Sales, Inc. (Laguna Niquel, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 National Medical Sales, Inc. devices

Submission Details

510(k) Number K903674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date January 04, 1991
Days to Decision 144 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 140d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 10
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