# K140194: Namic RCS Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Navilyst Medical, Inc.
- Decided: Apr 14, 2014 after 77 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: 2 generations back to K873955 (1988). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113198: Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML, Navilyst Medical, Inc. (2011) Summary page 1.
- K873955: Namic Angiographic Syringe, North American Instrument Corp. (1988) Summary page 1.

## Cited in the summary but kept off the family tree
- K087516: Piston Syringe. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K191659: Instylla Delivery Kit (2019), 3 descendants of its own
- 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 NAMIC RCS is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure.

Source page: https://510kreport.com/device/K140194
Methodology: https://510kreport.com/methodology