Cleared Traditional

K081743 - CLASSICSTAR NV SE AND NOVASTAR NV SE AN...

K081743 is an FDA 510(k) clearance for CLASSICSTAR NV SE AND NOVASTAR NV SE AN..., manufactured by Draeger Medical AG & Co. KG. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K081743 · Draeger Medical AG & Co. KG · Anesthesiology device
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Sep 2008
Decision
95d
Days
Class 2
Risk

K081743 is an FDA 510(k) clearance for the CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draeger Medical AG & Co. KG (Luebeck, DE). The FDA issued a Cleared decision on September 22, 2008 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 - K081743

510(k) Number K081743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2008
Decision Date September 22, 2008
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K081743.
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K071526 · Impact Instrumentation, Inc. · Dec 2008
ENGSTROM CARESTATION, ENGSTROM PRO
K081842 · Datex-Ohmeda, Inc. · Oct 2008
MODIFICATION TO HAMILTON-G5
K081521 · Hamilton Medical AG · Sep 2008
MODIFICATION TO GALILEO GOLD
K080181 · Hamilton Medical AG · Jun 2008
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
K073179 · Maquet Critical Care AB · Jun 2008
PERFORMAX SE TOTAL FACE MASK
K072588 · Respironics Inc., Sleep & Home Respiratory Group · Dec 2007