# K232328: Insignis™ Syringe Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health Sciences, LLC
- Decided: Mar 1, 2024 after 211 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: 3 generations back to K933652 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200176: FREEDOM Integrated Syringe Infusion System, Repro-Med Systems, Inc. Dba Koru Medical Systems (2021) Summary page 6.

## Indications for use
The Insignis™ Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21. For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider. The Insignis ™ Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and dextrose solutions, and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin. The Insignis™ Syringe Infusion System consists of the following components: • Insignis Syringe Driver • Intravenous Controller • OneSett Subcutaneous Administration Set The Insignis Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653)

Source page: https://510kreport.com/device/K232328
Methodology: https://510kreport.com/methodology