Cleared Traditional

K081447 - FOURTH GAS MODULE WITH CO2 FOR PRIMUS U...

K081447 is an FDA 510(k) clearance for FOURTH GAS MODULE WITH CO2 FOR PRIMUS U..., 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 139-day FDA review.

K081447 · Draeger Medical AG & Co. KG · Anesthesiology device
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Oct 2008
Decision
139d
Days
Class 2
Risk

K081447 is an FDA 510(k) clearance for the FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Draeger Medical AG & Co. KG (Luebeck, DE). The FDA issued a Cleared decision on October 8, 2008 after a review of 139 days - within the typical 510(k) review window.

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 - K081447

510(k) Number K081447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2008
Decision Date October 08, 2008
Days to Decision 139 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
1d faster than avg
Panel avg: 140d · This submission: 139d
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
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K081447.
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K081844 · Datex-Ohmeda, Inc. · Aug 2008
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K081941 · GE Healthcare Finland Oy · Aug 2008
GE DATEX-OHMEDA AISYS
K073707 · Datex-Ohmeda, Inc. · Jan 2008