# K170881: ISP Safety Huber Needle Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Infusion Safety Products, Inc.
- Decided: Dec 14, 2017 after 265 days
- Product code: PTI (Non-Coring (Huber) Needle)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890127 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 5.

## Indications for use
The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient’s surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle by encapsulating the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.

Source page: https://510kreport.com/device/K170881
Methodology: https://510kreport.com/methodology