# K993848: Millennium Huber Plus Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Medical Distribution, Inc.
- Decided: Jan 27, 2000 after 76 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: 1 generation back to K890127 (1989). 5 ancestors in all.
80 later devices descend from it; 7 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890127: Intravascular Administration Set, Multi-Med, Inc. (1989) Summary page 1.
- K890340: Intravascular Administration Set, Multi-Med, Inc. (1989) Summary page 1.
- K891072: Intravascular Administration Set, Multi-Med, Inc. (1989) Summary page 1.
- K891919: Intravascular Administration Set, Multi-Med, Inc. (1989) Summary page 1.
- K912563: Angel Wing Safety Blood Collection and Infusion SE, Mbo Laboratories, Inc. (1991) Summary page 1.

## Most influential descendants
- K013394: Liftloc Safety Infusion Set (2001), 70 descendants of its own
- 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
- K013871: Lifeguard Safety Infusion Set (2002), 24 descendants of its own

## Recalls of this device
- Jan 14, 2010 · Not classified · Z-0861-2010: After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
- Jan 14, 2010 · Not classified · Z-0862-2010: After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.

## Indications for use
The Millennium Huber Plus Safety Infusion Set is a safety IV administration set with a non-coring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Plus system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.

Source page: https://510kreport.com/device/K993848
Methodology: https://510kreport.com/methodology