# K033290: Talon Infusion Set, Model IP XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Apr 12, 2004 after 181 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) Glucopro Infusion Set: named in the summary without a submission number

## Most influential descendants
- K130468: Orbit Infusion Set (2013), 5 descendants of its own
- K150059: BD FlowSmart Set (2015), 3 descendants of its own
- K153257: BD FlowSmart Set, MiniMed Pro-Set (2015), 2 descendants of its own
- K160651: BD FlowSmart Set, MiniMed Pro-Set (2016), 1 descendant of its own
- K181718: BD FlowSmart Set/MiniMed Pro-Set (2018), 0 descendants of its own

## Recalls of this device
- Mar 1, 2011 · Not classified · Z-0592-2012: The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the Unite
- Mar 1, 2011 · Not classified · Z-0593-2012: The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the Unite
- Sep 26, 2006 · Not classified · Z-1166-2007: The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

## Indications for use
The Talon insulin pump infusion set is an administration infusion set intended to be used for subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump

Source page: https://510kreport.com/device/K033290
Methodology: https://510kreport.com/methodology