# K050600: Miniloc Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Health Products, Intl.
- Decided: May 12, 2005 after 64 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: 4 generations back to K890127 (1989). 9 ancestors in all.
67 later devices descend from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013394: Liftloc Safety Infusion Set, Specialized Health Products, Inc. (2001) Summary page 2.
- K042234: Modification to: Liftloc Saftey Infusion Set, Specialty Health Products, Inc. (2004) Summary page 1.

## Most influential descendants
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple (2006), 66 descendants of its own
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached) (2007), 20 descendants of its own
- K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set (2007), 20 descendants of its own
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle (2007), 18 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own

## Recalls of this device
- Dec 19, 2016 · Class II · Z-0985-2017: Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may 
- 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 MiniLoc TM Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular pods. The integral MiniLoc TM Safety Infusion Set safety mechanism is manually activated during the removal of the MiniLoc TM Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle. The MiniLoc TM Safety Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted pods. The MiniLocTM Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device. The MiniLoc TM Safety Infusion Set may be used in any appropriate patient population.

Source page: https://510kreport.com/device/K050600
Methodology: https://510kreport.com/methodology