Cleared Traditional

K874902 - SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY

K874902 is an FDA 510(k) clearance for SINGLE BREATH LUNG DIFFUS TEST DEVICE S..., manufactured by Gomi Medical Instruments. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K874902 · Gomi Medical Instruments · Anesthesiology device
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Jun 1988
Decision
189d
Days
Class 2
Risk

K874902 is an FDA 510(k) clearance for the SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Gomi Medical Instruments (San Anselmo, US). The FDA issued a Cleared decision on June 7, 1988 after a review of 189 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K874902

510(k) Number K874902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1987
Decision Date June 07, 1988
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
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 16
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K874902 · SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY
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