# K192647: neria guard Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Unomedical A/S
- Decided: Dec 13, 2019 after 80 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). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032854: Unomedical Monica Infusion Set, Unomedical A/S (2003) Summary page 5.

## Indications for use
The neriaTM guard infusion set is indicated for subcutaneous infusion of medication administered by an external pump.

Source page: https://510kreport.com/device/K192647
Methodology: https://510kreport.com/methodology