Cleared Traditional

K925217 - MERIDIAN MEDICAL SYSTEMS BREATHING FILTER

K925217 is the FDA 510(k) clearance for MERIDIAN MEDICAL SYSTEMS BREATHING FILTER by Merit Medical Systems, Inc.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K925217 · Merit Medical Systems, Inc. · General Hospital
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Jan 1993
Decision
102d
Days
Class 2
Risk

K925217 is an FDA 510(k) clearance for the MERIDIAN MEDICAL SYSTEMS BREATHING FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 102 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K925217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date January 26, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
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 59
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K925217.
STERIVENT AND STERIVENT S
K941676 · Mallinckrodt Medical · May 1994
BARRIERBAC AND BARRIERBAC S
K941536 · Mallinckrodt Medical · Apr 1994
HYGROBAC,S HYGROBOY AND HYGROBABY
K941381 · Mallinckrodt Medical · Apr 1994
VENTILATOR CIRCUITS
K920885 · Vital Signs, Inc. · Oct 1992
BACTERIA FILTER
K912577 · Vital Signs, Inc. · Apr 1992
BACTERIA FILTER
K904830 · Vital Signs, Inc. · Apr 1991