Cleared Traditional

K230483 - Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230483 · Passy-Muir, Inc. · General Hospital
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Sep 2023
Decision
205d
Days
Class 2
Risk

K230483 is an FDA 510(k) clearance for the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15). Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Passy-Muir, Inc. (Irvine, US). The FDA issued a Cleared decision on September 16, 2023 after a review of 205 days - an extended review 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: 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 Passy-Muir, Inc. devices

Submission Details

510(k) Number K230483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2023
Decision Date September 16, 2023
Days to Decision 205 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 128d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 200
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K230483.
Ambu® Virobac II® Exhalation Filter
K251583 · Ambu A/S · Apr 2026
Besmed Bacterial Filter and HMEF
K241339 · Besmed Health Business Corp · Nov 2024
Breathing circuit bacterial/viral filter
K222917 · Shaoxing Haitech Medical Products Co., Ltd. · Feb 2024
TNI Clear-Guard™ 3 angled breathing filter (1545020)
K223258 · Intersurgical , Ltd. · Jun 2023
Filter and HME/Filter
K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836 · Dr?gerwerk AG & Co KGaA · Dec 2022