Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXT — Predicate Candidate Screening
210 FDA 510(k) clearances under this product code; the 50 most recent screened below.
100 daysmedian FDA review time
302 days90th percentile
210clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (90 | Fortis Biosolutions Company Limited | 2026-05-14 | 265 | 0 |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mo | Acist Medical Systems, Inc. | 2026-05-13 | 264 | 0 |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Lo | Acist Medical Systems, Inc. | 2026-05-13 | 266 | 0 |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill | Shenzhen Maiwei Biotech Co., Ltd. | 2026-04-16 | 206 | 0 |
| K251788 | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | 2026-03-05 | 267 | 0 |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System | Bayer Medical Care, Inc. | 2026-02-13 | 155 | 0 |
| K244038 | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | 2025-09-05 | 249 | 0 |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | 2024-12-23 | 154 | 0 |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | 2024-08-27 | 29 | 0 |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and A | Shenzhen Boon Medical Supply Co., Ltd. | 2024-08-22 | 122 | 0 |
| K230668 | Disposable High-pressure Extension Lines | Precision Medical Plastics , Ltd. | 2024-06-14 | 462 | 0 |
| K232388 | High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd | 2023-11-21 | 104 | 0 |
| K211564 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2021-10-19 | 152 | 0 |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Deli | Acist Medical Systems, Inc. | 2020-12-17 | 77 | 0 |
| K201395 | Sterile High-pressure Angiographic Syringes for single-use | Youwo (Guangzhou) Medical Device Co., Ltd. | 2020-10-28 | 154 | 0 |
| K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | 2020-08-07 | 317 | 0 |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Works | Bayer Medical Care, Inc. | 2019-12-13 | 105 | 0 |
| K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | 2019-12-05 | 36 | 0 |
| K190102 | DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast M | Osprey Medical, Inc. | 2019-10-17 | 268 | 0 |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A100 | Acist Medical Systems, Inc. | 2019-07-18 | 87 | 0 |
| K183267 | DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Cont | Osprey Medical, Inc. | 2018-12-20 | 27 | 0 |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Works | Bayer Medical Care, Inc. | 2018-11-01 | 71 | 0 |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System | Bayer Medical Care, Inc. | 2018-11-01 | 71 | 0 |
| K181936 | DyeVert PLUS EZ Contrast Reduction System | Osprey Medical, Inc. | 2018-10-25 | 98 | 0 |
| K182289 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2018-10-10 | 48 | 0 |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Works | Bayer Medical Care, Inc. | 2018-08-17 | 248 | 0 |
| K172694 | Sterile Disposable Syringes | Shenyang Mastech Medical Device Co., Ltd. | 2018-07-06 | 302 | 0 |
| K171646 | ACISTCVi® Contrast Delivery System | Acist Medical Systems, Inc. | 2018-02-16 | 256 | 0 |
| K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018-02-07 | 93 | 0 |
| K170279 | Disposable High Pressure Syringe | Union Medical Shenzhen Co., Ltd. | 2017-12-12 | 316 | 0 |
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Pr | Coeur, Inc. | 2017-08-18 | 186 | 0 |
| K171698 | Smart Syringe | Osprey Medical, Inc. | 2017-07-07 | 29 | 0 |
| K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | 2017-06-15 | 224 | 0 |
| K171217 | DyeVert Plus Contrast Reduction System, DyeVert NG Contrast | Osprey Medical, Inc. | 2017-05-26 | 30 | 0 |
| K163054 | DyeVert Plus Contrast Modulation/Monitoring System, Contrast | Osprey Medical, Inc. | 2017-03-08 | 127 | 0 |
| K162088 | Ecomed Disposable Angiographic Syringes | Ecomed Solutions, LLC | 2017-01-27 | 183 | 0 |
| K152906 | Disposable High Pressure Injector Syringe | Wuxi Yushou Medical Appliances Co., Ltd. | 2016-11-22 | 418 | 0 |
| K160190 | Sunmed Control Syringes | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-11-10 | 288 | 0 |
| K161471 | MR Syringe Dual Pack for Solaris Injectors | Coeur, Inc. | 2016-10-06 | 132 | 0 |
| K161505 | DyeVert NG Contrast Modulation System | Osprey Medical, Inc. | 2016-08-03 | 63 | 0 |
| K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2016-07-29 | 192 | 1 |
| K152978 | DeRoyal Angiography Kits | Deroyal Industries, Inc. | 2016-03-25 | 168 | 0 |
| K153141 | DyeVert Contrast Modulation System | Osprey Medical, Inc. | 2016-02-04 | 97 | 0 |
| K151960 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016-01-07 | 175 | 0 |
| K150902 | 330psi Extension Y-Line with Dual Check Valve | Coeur, Inc. | 2015-10-22 | 202 | 0 |
| K151300 | AVERT Contrast Modulation System | Osprey Medical, Inc. | 2015-10-15 | 153 | 0 |
| K151746 | Dyevert Contrast Modulation System | Osprey Medical, Inc. | 2015-10-09 | 102 | 0 |
| K152218 | AVERT Contrast Modulation System;AVERT Contrast Modulation S | Osprey Medical | 2015-09-21 | 45 | 0 |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System | Bayer Medical Care, Inc. | 2015-08-14 | 242 | 0 |
| K142745 | 125mL CT Syringe | Coeur, Inc. | 2015-04-01 | 189 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda