Cleared Traditional

K890362 - OMNIFILTER MAIN FLOW BACTERIA FILTER

K890362 is an FDA 510(k) clearance for OMNIFILTER MAIN FLOW BACTERIA FILTER, manufactured by Puritan Bennett Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K890362 · Puritan Bennett Corp. · General Hospital
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Mar 1989
Decision
48d
Days
Class 2
Risk

K890362 is an FDA 510(k) clearance for the OMNIFILTER MAIN FLOW BACTERIA FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on March 14, 1989 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K890362

510(k) Number K890362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1989
Decision Date March 14, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K890362.
CHILD SIZE - FILTER FLEX (TM)
K893030 · Life Design Systems, Inc. · Sep 1989
RCI VIRAL/BACTERIAL FILTER
K892230 · Respiratory Care, Inc. · Aug 1989
BACTERIA FILTER
K890035 · Hudson Oxygen Therapy Sales Co. · May 1989
RESUSCITATION BAG EXHALATION FILTER
K883693 · Intertech Resources, Inc. · Sep 1988
SIEMENS MAIN FLOW BACTERIA FILTER
K871366 · Siemens Elema AB · May 1987
CURITY ANESTHESIA FILTER
K864103 · The Kendal Co. · Jan 1987