# K171735: PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 8, 2017 after 57 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: 10 generations back to K001901 (2000). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153440: PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set, C.R. Bard, Inc. (2016) Summary page 5.

## Most influential descendants
- K241353: PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (2024), 0 descendants of its own

## Indications for use
The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The needle is used to access surgically implanted vascular ports. The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration 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. 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. The SafeStep® Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® Huber Needle safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.

Source page: https://510kreport.com/device/K171735
Methodology: https://510kreport.com/methodology