Cleared Traditional

K831803 - PULMOMETER

K831803 is an FDA 510(k) clearance for PULMOMETER, manufactured by Kinetics Measurement Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K831803 · Kinetics Measurement Corp. · Anesthesiology device
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Apr 1984
Decision
332d
Days
Class 2
Risk

K831803 is an FDA 510(k) clearance for the PULMOMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Kinetics Measurement Corp. (Walker, US). The FDA issued a Cleared decision on April 30, 1984 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K831803

510(k) Number K831803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date April 30, 1984
Days to Decision 332 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 140d · This submission: 332d
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 184
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K831803.
SPIROMED 2
K851620 · Draeger Medical, Inc. · May 1985
ERGO-OXYSCREEN
K843841 · Erich Jaeger, Inc. · Dec 1984
PULMONARY FUNCTION SYSTEM
K842041 · Sensor Medics Corp. · Jun 1984
RESPIRODYNE PULMONARY FUNCTION TEST
K834475 · Chesebrough-Pond'S U.S.A. Co. · Feb 1984
BREATH METER
K810437 · Fred Sammons, Inc. · May 1981
DISPIRO
K791177 · Utah Medical Products, Inc. · Aug 1979
K831803 · PULMOMETER
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