Cleared Abbreviated

K022276 - KOKOMATE

K022276 is an FDA 510(k) clearance for KOKOMATE, manufactured by Ferraris Respiratory, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Abbreviated 510(k) pathway after a 81-day FDA review.

K022276 · Ferraris Respiratory, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
81d
Days
Class 2
Risk

K022276 is an FDA 510(k) clearance for the KOKOMATE. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Ferraris Respiratory, Inc. (Louisville, US). The FDA issued a Cleared decision on October 4, 2002 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ferraris Respiratory, Inc. devices

FDA 510(k) Submission Details - K022276

510(k) Number K022276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2002
Decision Date October 04, 2002
Days to Decision 81 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
Pathway characteristics
Standards-based clearance path.

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 100
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