# K972173: Medi-Sis Syringe Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Aug 15, 1997 after 67 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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: 1 generation back to K953028 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954059: Titan 20 CC Driver, I-Flow Corp. (1995) Summary page 2.
- K953028: Titan Driver 60CC, 30 Minute Administration Set, I-Flow Corp. (1995) Summary page 2.

## Most influential descendants
- K111381: Medi-Sis Syringe Infusion System (2012), 0 descendants of its own

## Indications for use
1. Medi-SIS Syringe Infusion System was designed for general drug and solution infusion uses with the limitation being the volume of drug to be infused. The routes of administration include those of the similar size syringes, (i.e. intravenous infusions and subcutaneous infusions). 2. The administration set is intended for single patient use only. 3. The Medi-SIS driver can be reused up to 5,000 times. 4. The Medi-SIS system is intended for general infusion use. The Medi-SIS Syringe Infusion System is not limited to any specific type of therapy. 4.1 The Medi-SIS Syringe Infusion System is not intended for the delivery of blood, blood products or TPN solutions.

Source page: https://510kreport.com/device/K972173
Methodology: https://510kreport.com/methodology