# K982047: MPS Huber Needle Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Medical Product Specialists
- Decided: Jul 21, 1998 after 41 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gish Vastack®: named in the summary without a submission number

## Most influential descendants
- K032934: MPS Acacia Safeguard Huber Device (2003), 3 descendants of its own
- K090809: MPS Acacia Power Injectable Infusion Set (2009), 2 descendants of its own
- K142527: Extension Set with BD Q-Syte Luer Access Split Septum (2014), 1 descendant of its own
- K202672: Precision Delivery Infusion Set (2021), 0 descendants of its own

## Indications for use
a. The MPS Huber Needle Extension Set is intended for use with implanted infusion ports for continuous or intermittent infusion therapy. b. For use for infusion of 1.V. fluids, blood, blood products and drugs. C. Change per CDC guidelines or per hospital Protocol.

Source page: https://510kreport.com/device/K982047
Methodology: https://510kreport.com/methodology