Cleared Traditional

K072884 - FABIUS MRI

K072884 is an FDA 510(k) clearance for FABIUS MRI, manufactured by Draeger Medical AG & Co. KG. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K072884 · Draeger Medical AG & Co. KG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
295d
Days
Class 2
Risk

K072884 is an FDA 510(k) clearance for the FABIUS MRI. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Draeger Medical AG & Co. KG (Telford, US). The FDA issued a Cleared decision on July 30, 2008 after a review of 295 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Draeger Medical AG & Co. KG devices

FDA 510(k) Submission Details - K072884

510(k) Number K072884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date July 30, 2008
Days to Decision 295 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
155d slower than avg
Panel avg: 140d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 115
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