# K242212: Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Nemoto Kyorindo Co., Ltd.
- Decided: Aug 27, 2024 after 29 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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 K934086 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051799: Disposable CT/MR Syringes for Nemoto Injectors, Coeur, Inc. (2005) Summary page 5.
- K090487: Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125, C855-5150, Coeur, Inc. (2009) Summary page 5.
- K120892: Disposable 330PSI Extension Lines, Coeur, Inc. (2013) Summary page 5.

## Indications for use
100 mL/200 mL Syringe: The Disposable Syringe (Kit) (100 mL or 200 mL Syringe) is a syringe for the injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors. 150 mL Syringe: The Disposable Syringe (Kit) (150 mL Syringe) is a syringe for the injection of contrast media or saline for angiography, for use on Nemoto injectors. J-Tube: J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the syringe of the Disposable Syringe (Kit). Extension Tubes: The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter that is punctured into the patient.

Source page: https://510kreport.com/device/K242212
Methodology: https://510kreport.com/methodology