# K253769: Instylla Delivery Kit

- Pathway: 510(k) (Special)
- Applicant: Instylla, Inc.
- Decided: Dec 22, 2025 after 27 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: 6 generations back to K873955 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213632: Instylla Delivery Kit, Instylla, Inc. (2022) Summary page 5.

## 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/K253769
Methodology: https://510kreport.com/methodology