Cleared Traditional

K063125 - FILTERFLO HEPA

Also marketed or referenced as:
THERMOFLO HEPA (FILTER / HME)

K063125 is an FDA 510(k) clearance for FILTERFLO HEPA, manufactured by Arc Medical, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K063125 · Arc Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
182d
Days
Class 2
Risk

K063125 is an FDA 510(k) clearance for the FILTERFLO HEPA. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Arc Medical, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on April 13, 2007 after a review of 182 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 - K063125

510(k) Number K063125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2006
Decision Date April 13, 2007
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 196
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K063125.
MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
K081536 · Medisize BV · Jan 2009
FILTER CARESTAR 30
K072002 · Draeger Medical AG & Co. KG · Jan 2008
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
K063526 · A-M Systems, Inc. · Jun 2007
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
K061426 · Porous Media Corp. · Jun 2006
BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
K052087 · Ag Industries · Dec 2005
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005
K063125 · FILTERFLO HEPA
Download PDF FDA Summary Arc Medical, Inc.