Bactagard Filter, Infusion Line
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K811773 FDA 510(k)
- FDA Product Code
- FPB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bactagard is a filter, infusion line designed to remove particulate matter from intravenous fluids and medications. It incorporates a sterile barrier to prevent microbial contamination during administration, ensuring the integrity of the infused solution while maintaining flow compatibility with standard infusion systems.
Supplied as a single-use, sterile device, the Bactagard is intended for use in general hospital settings. It adheres to FDA 510(k) clearance (K811773) under product code FPB, classified as a Class II device under regulation 880.5440. No MRI safety or reusable specifications are noted; storage should follow manufacturer guidelines for sterile, non-sterilized medical devices.
Frequently asked questions
What is the Bactagard infusion filter designed to do?
The Bactagard is a sterile, single-use infusion filter designed to remove particulate matter from intravenous fluids and medications. It also acts as a microbial barrier to prevent contamination during administration, ensuring the infused solution remains uncontaminated while maintaining compatibility with standard infusion systems.
Is the Bactagard filter reusable or intended for single-use?
The Bactagard is explicitly supplied as a single-use device. It is not designed for reuse, as its sterile barrier and filtration integrity are compromised after one use. Always follow manufacturer guidelines for proper disposal after use.
What type of hospital settings is the Bactagard intended for?
The Bactagard is intended for use in general hospital settings. Its design ensures compatibility with standard infusion systems, making it suitable for routine intravenous therapy where particulate and microbial contamination risks need to be mitigated.
How should the Bactagard filter be stored?
Storage instructions for the Bactagard should align with manufacturer guidelines for sterile, non-sterilized medical devices. It is critical to maintain sterility until use, as the device is provided in a sterile condition and is intended for single-use only.
What regulatory pathway does the Bactagard follow?
The Bactagard infusion filter is cleared under the FDA’s 510(k) pathway, specifically with clearance number K811773. It is classified as a Class II device under regulation 880.5440 and is substantially equivalent to predicate devices, ensuring it meets established safety and performance standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BACTAGARD (K811773) — FDA 510 (k) | Innolitics, Bactagard 510 (k) K811773 - FDA.report, 510 (k) K811773 — BACTAGARD — RegDataLab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811773 | Class II | Active |
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Manufacturer
- Manufacturer
- Tri-Med, Inc.
Sources (1)
- FDA 510(k) K811773 24 fields · synced Oct 1, 2026