# K113198: Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Nov 28, 2011 after 28 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873955 (1988). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873955: Namic Angiographic Syringe, North American Instrument Corp. (1988) Summary page 4.

## Most influential descendants
- K140194: Namic RCS Syringe (2014), 4 descendants of its own
- 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
- K163084: Merit Coronary Control Syringe (2017), 1 descendant of its own

## Recalls of this device
- Feb 27, 2026 · Class I · Z-1713-2026: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconn

## Indications for use
The NMI Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.

Source page: https://510kreport.com/device/K113198
Methodology: https://510kreport.com/methodology