# K140133: Infuset Flow Control Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Emed Technologies Corporation
- Decided: May 15, 2014 after 118 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: 1 generation back to K933652 (1994). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933652: Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing, Repro-Med Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K142319: SCIg60 Infuser, Infuset (2015), 6 descendants of its own
- K161906: SCIg60 Infuser (2016), 5 descendants of its own
- K222087: SCIg60 Infusion System (2022), 3 descendants of its own
- K240148: SCIg60 Infusion System (2024), 1 descendant of its own
- K251105: Tetra (TM-20); Tetra (TM-50) (2025), 0 descendants of its own

## Indications for use
The lnfusetTrM Flow Control Extension Set is intended for use with the RMS Freedom 60 Syringe Infusion Pump System to provide flow rate control to administer fluids from a contained to a patient's vascular system.

Source page: https://510kreport.com/device/K140133
Methodology: https://510kreport.com/methodology