# K032854: Unomedical Monica Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Unomedical A/S
- Decided: Oct 9, 2003 after 27 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: 1 generation back to K972135 (1997). 4 ancestors in all.
14 later devices descend from it; 8 cite it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991759: Maersk Medical Contour Infusion Set, Maersk Medical A/S (1999)
- K011071: Paradigm Quick-Set Infusion Set, Maersk Medical A/S (2001)
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set, P/L Biomedical (1997) Summary page 1.
- K992300: Quick-Serter, Model 395, Medtronic Minimed (1999) Summary page 1.

## Most influential descendants
- K173879: MiniMed Mio Advance infusion set (2018), 3 descendants of its own
- K061374: Intuition Infusion Sets (2006), 2 descendants of its own
- K243841: Sparta Infusion Set for Insulin (2025), 1 descendant of its own
- K242692: SteadiSet Infusion Set (2025), 1 descendant of its own
- K160648: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (2016), 1 descendant of its own

## Recalls of this device
- Jul 21, 2022 · Class II · Z-1810-2022: The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.

## Indications for use
Unomedical Monica Infusion Sets are indicated for the subcutaneous infusion of medication from an external pump.

Source page: https://510kreport.com/device/K032854
Methodology: https://510kreport.com/methodology