# K013394: Liftloc Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Specialized Health Products, Inc.
- Decided: Nov 8, 2001 after 24 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890127 (1989). 7 ancestors in all.
70 later devices descend from it; 3 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993848: Millennium Huber Plus Safety Infusion Set, Millennium Medical Distribution, Inc. (2000) Summary page 1.
- K863606: Butterfly Non-Coring Needle Set, Cormed, Inc., Sub. C.R.Bard, Inc. (1986) Summary page 1.

## Most influential descendants
- K042234: Modification to: Liftloc Saftey Infusion Set (2004), 68 descendants of its own
- K050600: Miniloc Safety Infusion Set (2005), 67 descendants of its own
- 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

## Recalls of this device
- Apr 17, 2003 · Not classified · Z-0837-03: Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.

## Indications for use
The LiftLoc™ Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports. The integral LiftLoc™ Safety Infusion Set safety mechanism is manually activated during the removal of the LiftLoc™ 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 LiftLoc™ Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. The LiftLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device. The LiftLoc™ Safety Infusion Set may be used in any appropriate patient population.

Source page: https://510kreport.com/device/K013394
Methodology: https://510kreport.com/methodology