# K191659: Instylla Delivery Kit

- Pathway: 510(k) (Traditional)
- Applicant: Instylla, Inc.
- Decided: Oct 10, 2019 after 111 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: 3 generations back to K873955 (1988). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140194: Namic RCS Syringe, Navilyst Medical, Inc. (2014) Summary page 4.
- K012868: Micromedics Fibrijet Aerosol Applicator, Micromedics, Inc. (2001) Summary page 4.

## Most influential descendants
- K202544: Instylla Delivery Kit (2021), 2 descendants of its own
- K213632: Instylla Delivery Kit (2022), 1 descendant of its own
- K253769: Instylla Delivery Kit (2025), 0 descendants of its own

## Indications for use
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

Source page: https://510kreport.com/device/K191659
Methodology: https://510kreport.com/methodology