# K831445: Infusion Sets #'S 124 & 142 Personal

- Pathway: 510(k) (Traditional)
- Applicant: Pacesetter Systems
- Decided: Sep 12, 1983 after 130 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
No predicates in its family tree.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961474: Polyfin Infusion Set MMT-106/MMT-107/MMT-133 (1996), 20 descendants of its own
- K020530: Evans Sub-Q, Model MC4206 (2002), 17 descendants of its own
- K140131: Sub-Q Subcutaneous Tissue Infusion Set (2014), 8 descendants of its own
- K142319: SCIg60 Infuser, Infuset (2015), 6 descendants of its own
- K082818: Subcutaneous Needle Infusion Set (2008), 6 descendants of its own

Source page: https://510kreport.com/device/K831445
Methodology: https://510kreport.com/methodology