Cleared Traditional

K091185 - 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER

K091185 is an FDA 510(k) clearance for 70530-BACTIAL/VIRAL FILTER, manufactured by Hsiner Co., Ltd.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K091185 · Hsiner Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
92d
Days
Class 2
Risk

K091185 is an FDA 510(k) clearance for the 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on July 24, 2009 after a review of 92 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.

View all Hsiner Co., Ltd. devices

FDA 510(k) Submission Details - K091185

510(k) Number K091185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2009
Decision Date July 24, 2009
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 156
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K091185.
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
THERMOFLO HCH, THERMOFLO FILTER
K090738 · Arc Medical, Inc. · Jul 2009
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