# K120195: Safety Subcutaneous Tissue Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Multi Med
- Decided: Jul 6, 2012 after 165 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: 4 generations back to K831445 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082818: Subcutaneous Needle Infusion Set, Marcal Medical, Inc. (2008) Summary page 2.

## Indications for use
The Safety Subcutaneous Infusion Set is designed specifically for the delivery of mnedications to the subcutaneous tissue.

Source page: https://510kreport.com/device/K120195
Methodology: https://510kreport.com/methodology