# K933652: Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Repro-Med Systems, Inc.
- Decided: May 18, 1994 after 294 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 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
- K140133: Infuset Flow Control Extension Set (2014), 7 descendants of its own
- K162613: Integrated Catch-up Freedom Syringe Driver Infusion System (2017), 6 descendants of its own
- 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

## Recalls of this device
- Mar 10, 2016 · Class II · Z-0317-2018: On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the sup

Source page: https://510kreport.com/device/K933652
Methodology: https://510kreport.com/methodology