# K190427: Immucise

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corporation
- Decided: Jul 18, 2019 after 146 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K771205 (1977). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181369: Immucise Intradermal Injection System, Terumo Corporation (2018) Summary page 4.

## Indications for use
The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.

Source page: https://510kreport.com/device/K190427
Methodology: https://510kreport.com/methodology