# K081210: Nipro Safetouch Huber Infustion Set

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Oct 21, 2008 after 175 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) EXEL SecureTouch Safety Huber Infusion Set: named in the summary without a submission number

## Most influential descendants
- K113470: Nipro Safe Touch Huber Infusion Set (2012), 0 descendants of its own

## Recalls of this device
- Dec 23, 2009 · Not classified · Z-0639-2010: Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extra

## 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/K081210
Methodology: https://510kreport.com/methodology