# K120872: Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps

- Pathway: 510(k) (Special)
- Applicant: Unomedical A/S Infusion Devices
- Decided: Apr 20, 2012 after 29 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972135 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032854: Unomedical Monica Infusion Set, Unomedical A/S (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K0972135: Unomedical Comfort. Number could not be read

## Most influential descendants
- K162812: Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set (2017), 0 descendants of its own

## Recalls of this device
- Nov 7, 2014 · Class II · Z-0357-2017: Tubing detachment
- Nov 7, 2014 · Class II · Z-0358-2017: Tubing detachment
- Nov 7, 2014 · Class II · Z-0355-2017: Tubing detachment
- Nov 19, 2013 · Class II · Z-0595-2014: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- Nov 19, 2013 · Class II · Z-0594-2014: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- Nov 19, 2013 · Class II · Z-0596-2014: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- Nov 19, 2013 · Class II · Z-0597-2014: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- Nov 19, 2013 · Class II · Z-0599-2014: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- Nov 19, 2013 · Class II · Z-0600-2014: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
- Nov 19, 2013 · Class II · Z-0601-2014: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.

## Indications for use
These infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.

Source page: https://510kreport.com/device/K120872
Methodology: https://510kreport.com/methodology