Cleared Traditional

K090738 - THERMOFLO HCH, THERMOFLO FILTER

K090738 is an FDA 510(k) clearance for THERMOFLO HCH, 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 129-day FDA review.

K090738 · Arc Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
129d
Days
Class 2
Risk

K090738 is an FDA 510(k) clearance for the THERMOFLO HCH, THERMOFLO FILTER. 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 July 27, 2009 after a review of 129 days - within the typical 510(k) review window.

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 - K090738

510(k) Number K090738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date July 27, 2009
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
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 K090738.
BACT-TRAP HEPA MIDI
K093426 · Pharma Systems AB · Feb 2010
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER
K091363 · Ag Industries · Feb 2010
FLEXICARE BREATHING FILTERS
K092218 · Flexicare Medical, Ltd. · Oct 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
FILTER CARESTAR 30
K072002 · Draeger Medical AG & Co. KG · Jan 2008
K090738 · THERMOFLO HCH, THERMOFLO FILTER
Download PDF FDA Summary Arc Medical, Inc.