# K241353: PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: Nov 27, 2024 after 198 days
- Product code: PTI (Non-Coring (Huber) Needle)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171735: PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set, C.R. Bard, Inc. (2017) Summary page 5.

## Indications for use
PowerLoc™ Max Power Injectable Infusion Set: The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles. SafeStep™ Huber Needle Set: The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. These devices may be used in any patient population with an implanted vascular port. Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

Source page: https://510kreport.com/device/K241353
Methodology: https://510kreport.com/methodology