Cleared Traditional

K892230 - RCI VIRAL/BACTERIAL FILTER

K892230 is the FDA 510(k) clearance for RCI VIRAL/BACTERIAL FILTER by Respiratory Care, Inc.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K892230 · Respiratory Care, Inc. · General Hospital
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Aug 1989
Decision
146d
Days
Class 2
Risk

K892230 is an FDA 510(k) clearance for the RCI VIRAL/BACTERIAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Respiratory Care, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 146 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 Respiratory Care, Inc. devices

Submission Details

510(k) Number K892230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1989
Decision Date August 28, 1989
Days to Decision 146 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
17d slower than avg
Panel avg: 129d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K892230.
VENTILATOR CIRCUITS
K920885 · Vital Signs, Inc. · Oct 1992
BACTERIA FILTER
K912577 · Vital Signs, Inc. · Apr 1992
BACTERIA FILTER
K904830 · Vital Signs, Inc. · Apr 1991
OMNIFILTER MAIN FLOW BACTERIA FILTER
K890362 · Puritan Bennett Corp. · Mar 1989
GASLINE FILTER, #EC-GLF SERIES
K832935 · Gish Biomedical, Inc. · Nov 1983
BREATHING CIRCUIT BACTERIA FILTER
K831856 · Vital Signs, Inc. · Sep 1983