Cleared Traditional

K863953 - SPIROMETRICS MODEL 2500 FLOWMATE(TM)

K863953 is an FDA 510(k) clearance for SPIROMETRICS MODEL 2500 FLOWMATE(TM), manufactured by Spirometrics, Inc.. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K863953 · Spirometrics, Inc. · Anesthesiology device
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Jan 1987
Decision
97d
Days
Class 2
Risk

K863953 is an FDA 510(k) clearance for the SPIROMETRICS MODEL 2500 FLOWMATE(TM). Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Spirometrics, Inc. (Arlington, US). The FDA issued a Cleared decision on January 15, 1987 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1900 - 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 Spirometrics, Inc. devices

FDA 510(k) Submission Details - K863953

510(k) Number K863953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1986
Decision Date January 15, 1987
Days to Decision 97 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 140d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZM Device Classification - Class 2, Special Controls

Product Code BZM Calculator, Pulmonary Function Interpretor (diagnostic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1900
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 - BZM Calculator, Pulmonary Function Interpretor (diagnostic)

All 15
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