Product code DXT: 510(k) clearances and predicates
Product code DXT covers 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. FDA lists 210 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
210 clearances on file under product code DXT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 so far | 6 |
Recent clearances
Newest DXT clearances in the FDA index, with applicant and decision date:
- K252652, 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, applicant Fortis Biosolutions Company Limited, decided 2026-05-14. FDA record
- K252653, ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable, applicant Acist Medical Systems, Inc., decided 2026-05-13. FDA record
- K252638, 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), applicant Acist Medical Systems, Inc., decided 2026-05-13. FDA record
- K253048, High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube, applicant Shenzhen Maiwei Biotech Co., Ltd., decided 2026-04-16. FDA record
- K251788, Extension tube, applicant Zhuhai DR Medical Instruments Co., Ltd., decided 2026-03-05. FDA record
- K252891, MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2), applicant Bayer Medical Care, Inc., decided 2026-02-13. FDA record
- K244038, High Pressure Tubing, applicant Shandong Int Medical Instruments Co., Ltd., decided 2025-09-05. FDA record
- K242143, Angiography Injector, applicant Shandong Int Medical Instruments Co., Ltd., decided 2024-12-23. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable, 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). Watch new DXT clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DXT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DXT clearances include 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.
How many 510(k) clearances use product code DXT?
210 at the time this page was generated, from openFDA records.
How do I find a predicate device under DXT?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DXT clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.