Cleared Traditional

K093174 - SPIROPALM

K093174 is an FDA 510(k) clearance for SPIROPALM, manufactured by Cosmed Srl. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K093174 · Cosmed Srl · Anesthesiology device
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Feb 2010
Decision
141d
Days
Class 2
Risk

K093174 is an FDA 510(k) clearance for the SPIROPALM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Cosmed Srl (West Caldwell, US). The FDA issued a Cleared decision on February 26, 2010 after a review of 141 days - within the typical 510(k) review window.

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. 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 Cosmed Srl devices

FDA 510(k) Submission Details - K093174

510(k) Number K093174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2009
Decision Date February 26, 2010
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
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.

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