Cleared Traditional

K072002 - FILTER CARESTAR 30

Also marketed or referenced as:
FILTER SAFESTAR 55 FILTER/HME TWINSTAR 55

K072002 is an FDA 510(k) clearance for FILTER CARESTAR 30, manufactured by Draeger Medical AG & Co. KG. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K072002 · Draeger Medical AG & Co. KG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
192d
Days
Class 2
Risk

K072002 is an FDA 510(k) clearance for the FILTER CARESTAR 30. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Draeger Medical AG & Co. KG (Telford, US). The FDA issued a Cleared decision on January 31, 2008 after a review of 192 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K072002

510(k) Number K072002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2007
Decision Date January 31, 2008
Days to Decision 192 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 129d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 168
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K072002.
THERMOFLO HCH, THERMOFLO FILTER
K090738 · Arc Medical, Inc. · Jul 2009
70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
K091185 · Hsiner Co., Ltd. · Jul 2009
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
K081536 · Medisize BV · Jan 2009
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
K063526 · A-M Systems, Inc. · Jun 2007
FILTERFLO HEPA
K063125 · Arc Medical, Inc. · Apr 2007
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
K061426 · Porous Media Corp. · Jun 2006