Cleared Traditional

K071533 - FITMATE SERIES

K071533 is an FDA 510(k) clearance for FITMATE SERIES, manufactured by Cosmed Srl. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K071533 · Cosmed Srl · Anesthesiology device
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Sep 2007
Decision
115d
Days
Class 2
Risk

K071533 is an FDA 510(k) clearance for the FITMATE SERIES. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Cosmed Srl (West Caldwell, US). The FDA issued a Cleared decision on September 28, 2007 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - 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 - K071533

510(k) Number K071533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2007
Decision Date September 28, 2007
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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 - BZL Computer, Oxygen-uptake

All 12
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