Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
FDA 510(k) K242212 · Nemoto Kyorindo Co., Ltd.
510(k) numberK242212
Submission
- Device name
- Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
- Applicant
- Nemoto Kyorindo Co., Ltd.
Tokyo, JP - Received
- July 29, 2024
- Decision date
- August 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DXT – Injector And Syringe, Angiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code DXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional | Fortis Biosolutions Company Limited | 05/14/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional | Shenzhen Maiwei Biotech Co., Ltd. | 04/16/2026SE |
| K251788 | Extension tubeDXT · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 03/05/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | Bayer Medical Care, Inc. | 02/13/2026SE |
| K244038 | High Pressure TubingDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 09/05/2025SE |
| K242143 | Angiography InjectorDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 12/23/2024SE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/22/2024SE |
| K230668 | Disposable High-pressure Extension LinesDXT · Traditional | Precision Medical Plastics , Ltd. | 06/14/2024SE |
More from Precision Medical Plastics , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K173450 | PRESS DUO elite, PRESS DUO elite AGDXT · Traditional | 02/07/2018SE |
| K133189 | Dual Shot Alpha 7DXT · Special | 06/30/2014SE |
| K092896 | Rempress and Angiography Contrast Delivery System RempressDXT · Traditional | 10/29/2010SE |
| K091734 | Sonic Shot GXIZQ · Traditional | 05/21/2010SE |
| K071691 | Dual Shot AlphaDXT · Special | 12/19/2007SE |
| K062168 | Contrast Delivery System - Dual Shot AlphaDXT · Traditional | 08/18/2006SE |
| K052633 | Dual Shot - Contrast Delivery SystemDXT · Traditional | 10/17/2005SE |
Questions and answers
When was Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) cleared by the FDA?
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212) received a 510(k) decision of Substantially Equivalent on August 27, 2024, 29 days after the submission was received.
What is the product code of K242212?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.