# K061374: Intuition Infusion Sets

- Pathway: 510(k) (Traditional)
- Applicant: Unomedical A/S
- Decided: Jul 31, 2006 after 75 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: 2 generations back to K972135 (1997). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011071: Paradigm Quick-Set Infusion Set, Maersk Medical A/S (2001) Summary page 1.
- 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.
- K010377: Mimimed Sil-Serter Infusion Set Insertion System, Model 385, Minimed, Inc. (2001) Summary page 1.

## Most influential descendants
- K242692: SteadiSet Infusion Set (2025), 1 descendant of its own
- K251854: SteadiSet infusion set (2025), 0 descendants of its own

## 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/K061374
Methodology: https://510kreport.com/methodology