# K013871: Lifeguard Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Horizon Medical Products, Inc.
- Decided: Mar 29, 2002 after 128 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (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.
24 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921674: Lifeport Infusion Set and Infusion Set W/ Y Site, Strato Medical Corp. (1992) Summary page 1.
- K993848: Millennium Huber Plus Safety Infusion Set, Millennium Medical Distribution, Inc. (2000) Summary page 1.

## Most influential descendants
- K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set (2007), 20 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- 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
- K072375: Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set (2007), 5 descendants of its own
- K081472: Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports (2008), 4 descendants of its own

## Recalls of this device
- Jul 24, 2017 · Class II · Z-0679-2018: Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyve
- Jan 21, 2013 · Class II · Z-0914-2013: The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the 
- Nov 16, 2010 · Not classified · Z-1327-2011: Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

## Indications for use
The LifeGuard™ Safety Infusion Set is used to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard™ Safety Infusion Set facilitates safe removal of the needle by encapsulating the needle during vascular port de-accessing to help prevent needlestick injuries.

Source page: https://510kreport.com/device/K013871
Methodology: https://510kreport.com/methodology