Cleared Traditional

K823257 - NON-REUSABLE UNIVERSAL NEBULIZER FILTE

K823257 is the FDA 510(k) clearance for NON-REUSABLE UNIVERSAL NEBULIZER FILTE by Ohio Medical Products. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K823257 · Ohio Medical Products · General Hospital
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Dec 1982
Decision
38d
Days
Class 2
Risk

K823257 is an FDA 510(k) clearance for the NON-REUSABLE UNIVERSAL NEBULIZER FILTE. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 38 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 Ohio Medical Products devices

Submission Details

510(k) Number K823257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date December 09, 1982
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 K823257.
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
3M BRAND ANESTHESIA FILTER,#3110
K760611 · 3M Company · Sep 1976
FILTER, RESPIRATORY (U-MID)
K760041 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1976