# K073050: Safestep Max Power-Injectable Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Health Products International, Inc.
- Decided: Jan 25, 2008 after 88 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 35 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040527: Low Profile Luther Safety Huber, Luther Needlesafe Products, Inc. (2004) Summary page 1.
- K021565: Luther Safety Huber Needle Set, Luther Research Partners (2002) Summary page 1.
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 3.
- K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set, Rita Medical Systems, Inc. (2007) Summary page 3.
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle, Smiths Medical MD, Inc. (2007) Summary page 2.

## Most influential descendants
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), 6 descendants of its own
- K230715: Promisemed Safety Huber Needle (2023), 2 descendants of its own
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set (2021), 2 descendants of its own
- K153440: PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set (2016), 2 descendants of its own
- K090809: MPS Acacia Power Injectable Infusion Set (2009), 2 descendants of its own

## Recalls of this device
- Mar 13, 2015 · Class II · Z-1560-2015: Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) wa
- Aug 8, 2014 · Class II · Z-1273-2015: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of 

## Indications for use
The SafeStep® MAXTM Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports. The SafeStep® MAXTM 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 SafeStep® MAXTM Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 mi/s for 22 gauge needles.

Source page: https://510kreport.com/device/K073050
Methodology: https://510kreport.com/methodology