PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241353 FDA 510(k)
- FDA Product Code
- PTI FDA 510(k)
- Models / Variants
- PowerLoc™ Max Power Injectable Infusion Set FDA 510(k)SafeStep™ Huber Needle Set FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5570 FDA 510(k)
- Regulation Number
- 880.5570 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Non-Coring (Huber) Needle infusion system designed for subcutaneous or intramuscular power injection of fluids, including contrast media. The PowerLoc Max component delivers high-pressure infusion capabilities, while the SafeStep Huber Needle Set ensures secure port septum insertion and fluid administration without coring the septum.
The PowerLoc Max Power Injectable Infusion Set and SafeStep Huber Needle Set are supplied as a combined system for use in general hospital settings. Both components are intended for single-use only and require sterile handling. The SafeStep Huber Needle Set is compatible with power injection rates of up to 5 ml/s for 19G/20G needles and 2 ml/s for 22G needles, as specified in the device’s design. Authorized under FDA 510(k) clearance (K241353), these devices adhere to regulatory standards for infusion systems classified under device class 2.
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: PowerLoc™ MAX Power Injectable Safety Infusion Set - BD, PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set ..., PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241353 | Class II | Active |
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Manufacturer
- Manufacturer
- Bard Access Systems, Inc.
Sources (1)
- FDA 510(k) K241353 24 fields · synced Sep 19, 2026