Cleared Special

K090486 - ASTHMA MONITOR MODEL, AM1 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090486 · Cardinal Health Germany 234 GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
70d
Days
Class 2
Risk

K090486 is an FDA 510(k) clearance for the ASTHMA MONITOR MODEL, AM1. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Cardinal Health Germany 234 GmbH (Palm Springs, US). The FDA issued a Cleared decision on May 6, 2009 after a review of 70 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardinal Health Germany 234 GmbH devices

Submission Details

510(k) Number K090486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date May 06, 2009
Days to Decision 70 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 139d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

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