Cleared Traditional

K874902 - SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874902 · Gomi Medical Instruments · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Gomi Medical Instruments devices

Submission Details

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
50d slower than avg
Panel avg: 139d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.