Cleared Traditional

K892520 - BREATHING CIRCUIT BACTERIAL FILTERS

K892520 is an FDA 510(k) clearance for BREATHING CIRCUIT BACTERIAL FILTERS, manufactured by Arbo Medical, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K892520 · Arbo Medical, Inc. · General Hospital
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Aug 1989
Decision
113d
Days
Class 2
Risk

K892520 is an FDA 510(k) clearance for the BREATHING CIRCUIT BACTERIAL FILTERS. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Arbo Medical, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 2, 1989 after a review of 113 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 Arbo Medical, Inc. devices

FDA 510(k) Submission Details - K892520

510(k) Number K892520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date August 02, 1989
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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 75
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K892520.
BACTERIA FILTER
K912577 · Vital Signs, Inc. · Apr 1992
BACTERIA FILTER
K904830 · Vital Signs, Inc. · Apr 1991
CHILD SIZE - FILTER FLEX (TM)
K893030 · Life Design Systems, Inc. · Sep 1989
BACTERIA FILTER
K890035 · Hudson Oxygen Therapy Sales Co. · May 1989
OMNIFILTER MAIN FLOW BACTERIA FILTER
K890362 · Puritan Bennett Corp. · Mar 1989
RESUSCITATION BAG EXHALATION FILTER
K883693 · Intertech Resources, Inc. · Sep 1988