# K051264: Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps

- Pathway: 510(k) (Traditional)
- Applicant: Unomedical A/S
- Decided: Sep 1, 2005 after 108 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
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)
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set, P/L Biomedical (1997) Summary page 1.
- K032854: Unomedical Monica Infusion Set, Unomedical A/S (2003) Summary page 1.

## 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
- May 16, 2011 · Not classified · Z-0202-2012: The consignee received four (4) boxes of mio infusion sets (MMT-921) that were shipped to them in error. These infusion sets were shipped in a package that included a MiniMed Paradigm REAL-TIME Insuli

## Indications for use
These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Source page: https://510kreport.com/device/K051264
Methodology: https://510kreport.com/methodology