DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Medrad, Inc., Osprey Medical, Inc. and Coeur, Inc..

210
Total
210
Cleared
146d
Avg days
1978
Since
Growing category - 8 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 228d recently vs 143d historically

FDA 510(k) Cleared Injector And Syringe, Angiographic Devices (Product Code DXT)

210 devices
1–24 of 210
Cleared May 14, 2026
Disposable Syringes with Accessories for Power Injectors (900103T)
K252652
Fortis Biosolutions Company Limited
General Hospital · 265d
Cleared May 13, 2026
VeraPro S100 Multi-Use Syringe (018808)
K252638
Acist Medical Systems, Inc.
General Hospital · 266d
Cleared May 13, 2026
ACIST Pro Diagnostic System (019304)
K252653
Acist Medical Systems, Inc.
General Hospital · 264d
Cleared Apr 16, 2026
High Pressure Syringe
K253048
Shenzhen Maiwei Biotech Co., Ltd.
General Hospital · 206d
Cleared Mar 05, 2026
Extension tube
K251788
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 267d
Cleared Feb 13, 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K252891
Bayer Medical Care, Inc.
General Hospital · 155d
Cleared Sep 05, 2025
High Pressure Tubing
K244038
Shandong Int Medical Instruments Co., Ltd.
General Hospital · 249d
Cleared Dec 23, 2024
Angiography Injector
K242143
Shandong Int Medical Instruments Co., Ltd.
General Hospital · 154d
Cleared Aug 27, 2024
Disposable Syringe (Kit)
K242212
Nemoto Kyorindo Co., Ltd.
General Hospital · 29d
Cleared Aug 22, 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 122d
Cleared Jun 14, 2024
Disposable High-pressure Extension Lines
K230668
Precision Medical Plastics , Ltd.
General Hospital · 462d
Cleared Nov 21, 2023
High Pressure Tubing
K232388
Ningbo Dizegens Medical Science Co.,Ltd
General Hospital · 104d
Cleared Oct 19, 2021
Sterile High-pressure Angiographic Syringes for Single-use
K211564
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 152d
Cleared Dec 17, 2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
K203004
Acist Medical Systems, Inc.
General Hospital · 77d
Cleared Oct 28, 2020
Sterile High-pressure Angiographic Syringes for single-use
K201395
Youwo (Guangzhou) Medical Device Co., Ltd.
General Hospital · 154d
Cleared Aug 07, 2020
Sterile High-pressure Angiographic Syringes for Single-use
K192657
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 317d
Cleared Dec 13, 2019
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370
Bayer Medical Care, Inc.
General Hospital · 105d
Cleared Dec 05, 2019
MEDRAD Mark 7 Arterion Injection System
K193028
Bayer Medical Care, Inc.
General Hospital · 36d
Cleared Oct 17, 2019
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System
K190102
Osprey Medical, Inc.
General Hospital · 268d
Cleared Jul 18, 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
K191060
Acist Medical Systems, Inc.
General Hospital · 87d
Cleared Dec 20, 2018
DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
K183267
Osprey Medical, Inc.
Cardiovascular · 27d
Cleared Nov 01, 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
K182273
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Nov 01, 2018
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K182276
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Oct 25, 2018
DyeVert PLUS EZ Contrast Reduction System
K181936
Osprey Medical, Inc.
Cardiovascular · 98d

About Product Code DXT - Regulatory Context

510(k) Submission Activity

210 total 510(k) submissions under product code DXT since 1978, with 210 receiving FDA clearance (average review time: 146 days).

Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXT Product Code

Recent submissions under DXT have taken an average of 228 days to reach a decision - up from 143 days historically. Manufacturers should account for longer review timelines in current project planning.

DXT devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →