Cleared Special

K023289 - OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072

K023289 is an FDA 510(k) clearance for OPTION NIV, manufactured by Drager Medizintechnik GmbH. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 105-day FDA review.

K023289 · Drager Medizintechnik GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
105d
Days
Class 2
Risk

K023289 is an FDA 510(k) clearance for the OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Drager Medizintechnik GmbH (Telford, US). The FDA issued a Cleared decision on January 15, 2003 after a review of 105 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023289

510(k) Number K023289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2002
Decision Date January 15, 2003
Days to Decision 105 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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 488
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K023289.
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K023366 · Datex-Ohmeda, Inc. · Oct 2003
PNEUTON VENTILATOR
K024344 · Airon Corporation · Jun 2003
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
K030515 · Hans Rudolph, Inc. · May 2003
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012691 · Acutronic Medical Systems AG · Dec 2002
INSPIRATION VENTILATOR SYSTEM
K021112 · eVent Medical, Ltd. · Nov 2002
K023289 · OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
Download PDF FDA Summary Drager Medizintechnik…