# K111381: Medi-Sis Syringe Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Acacia, Inc.
- Decided: Jan 13, 2012 after 241 days
- Product code: LZH (Pump, Infusion, Enteral)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K904518 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953028: Titan Driver 60CC, 30 Minute Administration Set, I-Flow Corp. (1995) Summary page 1.
- K954059: Titan 20 CC Driver, I-Flow Corp. (1995) Summary page 1.
- K972173: Medi-Sis Syringe Infusion System, I-Flow Corp. (1997) Summary page 1.
- K062699: Perfusor Space Infusion Syringe Pump System, B.Braun Medical, Inc. (2006) Summary page 1.

## Indications for use
The Medi-SIS Syringe Infusion System is indicated for the delivery of enteral fluids through clinically accepted routes of administration. The Medi-SIS Administration Extension Set is intended for single patient use only. The Medi-SIS Syringe Driver can be reused up to 5,000 times

Source page: https://510kreport.com/device/K111381
Methodology: https://510kreport.com/methodology