# K113470: Nipro Safe Touch Huber Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Oct 17, 2012 after 330 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
Longest line of descent: 1 generation back to K081210 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081210: Nipro Safetouch Huber Infustion Set, Nipro Medical Corp. (2008) Summary page 1.

## Indications for use
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.

Source page: https://510kreport.com/device/K113470
Methodology: https://510kreport.com/methodology