Cleared Traditional

CARINA SYSTEM, MODEL 8419350 (K072885) - FDA 510(k) Clearance

Also marketed or referenced as:
CARINA BASIC DEVICE, MODEL 5704110

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072885 · Draeger Medical AG & Co. KG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
181d
Days
Class 2
Risk

K072885 is an FDA 510(k) clearance for the CARINA SYSTEM, MODEL 8419350. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draeger Medical AG & Co. KG (Telford, US). The FDA issued a Cleared decision on April 7, 2008 after a review of 181 days - an extended review cycle.

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

Submission Details

510(k) Number K072885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date April 07, 2008
Days to Decision 181 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
41d slower than avg
Panel avg: 140d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 112
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K072885.
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
K063650 · Puritan Bennett Corp. · Feb 2007
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
K053388 · Puritan Bennett Corp. · Apr 2006
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004