Cleared Traditional

K222917 - Breathing circuit bacterial/viral filter (FDA 510(k) Clearance)

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

K222917 · Shaoxing Haitech Medical Products Co., Ltd. · General Hospital
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Feb 2024
Decision
507d
Days
Class 2
Risk

K222917 is an FDA 510(k) clearance for the Breathing circuit bacterial/viral filter. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Shaoxing Haitech Medical Products Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on February 15, 2024 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Shaoxing Haitech Medical Products Co., Ltd. devices

Submission Details

510(k) Number K222917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2022
Decision Date February 15, 2024
Days to Decision 507 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
379d slower than avg
Panel avg: 128d · This submission: 507d
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 200
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K222917.
Ambu® Virobac II® Exhalation Filter
K251583 · Ambu A/S · Apr 2026
Besmed Bacterial Filter and HMEF
K241339 · Besmed Health Business Corp · Nov 2024
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · Passy-Muir, Inc. · Sep 2023
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