Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
IZQ — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
147 daysmedian FDA review time
268 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | 2026-08-03 | 41 | 0 |
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 ( | Ulrich GmbH & Co. KG | 2025-11-18 | 119 | 0 |
| K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | 2025-11-07 | 196 | 0 |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set | Imaxeon Pty, Ltd. | 2025-09-24 | 29 | 0 |
| K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set | Imaxeon Pty, Ltd. | 2024-11-05 | 131 | 0 |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 ( | Ulrich GmbH & Co. KG | 2024-08-26 | 60 | 0 |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 ( | Ulrich GmbH & Co. KG | 2024-04-19 | 149 | 0 |
| K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2021-08-06 | 163 | 0 |
| K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | 2020-07-02 | 268 | 0 |
| K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2017-11-09 | 182 | 0 |
| K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Ty | Bracco Injeneering | 2016-01-22 | 277 | 0 |
| K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; | Liebel-Flarsheim Company, LLC | 2016-01-14 | 147 | 0 |
| K091734 | SONIC SHOT GX | Nemoto Kyorindo Co., Ltd. | 2010-05-21 | 344 | 0 |
| K063503 | OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007-04-27 | 158 | 1 |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | E-Z-Em, Inc. | 2007-04-13 | 234 | 0 |
| K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | Medrad, Inc. | 2007-03-27 | 168 | 0 |
| K062265 | CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM | Swiss Medical Care S.A. | 2006-12-26 | 144 | 0 |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | E-Z-Em, Inc. | 2003-06-19 | 30 | 3 |
| K983314 | PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM | Nycomed Amersham Imaging | 1999-02-19 | 151 | 0 |
| K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H | Acist Medical Systems | 1999-02-11 | 90 | 0 |
| K951005 | KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) | Kenex , Ltd. | 1995-05-04 | 78 | 0 |
| K760643 | MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-10-08 | 24 | 0 |
| K760641 | MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-10-08 | 24 | 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