# K891919: Intravascular Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Multi-Med, Inc.
- Decided: May 5, 1989 after 39 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 75 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
81 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993848: Millennium Huber Plus Safety Infusion Set (2000), 80 descendants of its own
- 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

## Recalls of this device
- Aug 30, 2010 · Not classified · Z-2508-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2536-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2516-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2558-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2535-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2518-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2549-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2527-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2515-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2563-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2568-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2550-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2578-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2539-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2561-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2552-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2560-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2546-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2538-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2540-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2520-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2511-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2564-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2575-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2533-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2573-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2559-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2569-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2548-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2544-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2513-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2543-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2577-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2551-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2510-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2571-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2522-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2526-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2529-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2562-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2567-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2534-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2528-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2542-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2509-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2574-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2532-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2537-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2521-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.
- Aug 30, 2010 · Not classified · Z-2576-2010: Huber needles may core and result in port leakage or emboli being flushed our of the port.

Source page: https://510kreport.com/device/K891919
Methodology: https://510kreport.com/methodology