Cleared Traditional

K223258 - TNI Clear-Guard™ 3 angled breathing filter (1545020) (FDA 510(k) Clearance)

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

K223258 · Intersurgical , Ltd. · General Hospital
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Jun 2023
Decision
237d
Days
Class 2
Risk

K223258 is an FDA 510(k) clearance for the TNI Clear-Guard™ 3 angled breathing filter (1545020). Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Intersurgical , Ltd. (Berkshire, GB). The FDA issued a Cleared decision on June 15, 2023 after a review of 237 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 Intersurgical , Ltd. devices

Submission Details

510(k) Number K223258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2022
Decision Date June 15, 2023
Days to Decision 237 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
109d slower than avg
Panel avg: 128d · This submission: 237d
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 Consultant

Intersurgical Incorporated
Kerrie Campbell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K223258.
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
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · Passy-Muir, Inc. · Sep 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