FDA product code DXT: Injector And Syringe, Angiographic
DXT is the FDA product code for injector and syringe, angiographic. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel. FDA has cleared 210 510(k) submissions under DXT, 12 in the last five years, from 88 different applicants. The average 510(k) review took 146 days (median 99); 226 days on average over the last three years. FDA has posted 70 recalls for DXT devices, 21 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Injector And Syringe, Angiographic |
| Device class | Class II |
| Regulation | 21 CFR 870.1650 |
| Review panel | HO — General Hospital |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DXT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 156 |
| 2018 | 9 | 135 |
| 2019 | 4 | 124 |
| 2020 | 3 | 183 |
| 2021 | 1 | 152 |
| 2023 | 1 | 104 |
| 2024 | 4 | 192 |
| 2025 | 1 | 249 |
| 2026 | 6 | 237 |
Compare with all 510(k) review times · Search every DXT clearance
Top DXT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medrad, Inc. | 32 | 2011-12-15 |
| Osprey Medical, Inc. | 14 | 2019-10-17 |
| Coeur, Inc. | 10 | 2017-08-18 |
| Acist Medical Systems, Inc. | 8 | 2026-05-13 |
| Bayer Medical Care, Inc. | 7 | 2026-02-13 |
83 more applicants have DXT clearances. See the full list in Caduvo.
Most recent DXT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252652 | Fortis Biosolutions Company Limited | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | 2026-05-14 | 265 |
| K252653 | Acist Medical Systems, Inc. | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | 2026-05-13 | 264 |
| K252638 | Acist Medical Systems, Inc. | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | 2026-05-13 | 266 |
| K253048 | Shenzhen Maiwei Biotech Co., Ltd. | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | 2026-04-16 | 206 |
| K251788 | Zhuhai DR Medical Instruments Co., Ltd. | Extension tube | 2026-03-05 | 267 |
Recalls for DXT devices
70 product recalls in 46 recall events; 21 initiated in the last five years and 21 still open. Most recent: 2026-07-31.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 2 |
| 2024 | 11 |
| 2026 | 8 |
Frequently asked questions
What is FDA product code DXT?
DXT is the FDA product code for injector and syringe, angiographic. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel.
What device class is DXT?
Class II, regulation 21 CFR 870.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code DXT?
Across 210 cleared submissions the average was 146 days from receipt to decision (median 99).
Which companies have the most DXT clearances?
Medrad, Inc. (32); Osprey Medical, Inc. (14); Coeur, Inc. (10); Acist Medical Systems, Inc. (8); Bayer Medical Care, Inc. (7).
Have DXT devices been recalled?
Yes: 70 product recalls across 46 recall events; the most recent began 2026-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DXT
- Run a recall and safety report across every DXT manufacturer
- Watch product code DXT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times