# K120395: Neria Multi Subcutaneous Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Unomedical Devices S.A DE C.V.
- Decided: May 30, 2012 after 112 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: 4 generations back to K831445 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945617: Pharma-Plast Pureline (TM) Basic (TM) and Pureline (TM) Contact (TM) Subcutaneous Infusion Sets, Pharma-Plast Intl. A/S (1995) Summary page 1.
- K082818: Subcutaneous Needle Infusion Set, Marcal Medical, Inc. (2008) Summary page 1.

## Recalls of this device
- May 21, 2015 · Class II · Z-1821-2015: Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.

## Indications for use
The sets are intended 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/K120395
Methodology: https://510kreport.com/methodology