Disposable Syringes with Accessories for Power Injectors (7+ models)— 510(k) K252652
Substantially EquivalentFortis Biosolutions Company Limited
FDA 510(k) clearance K252652 for Disposable Syringes with Accessories for Power Injectors (7+ models), Substantially Equivalent on 2026-05-14. Applicant: Fortis Biosolutions Company Limited. Device class: 2.
Summary
Fortis Biosolutions' record lists Disposable Syringes with Accessories for Power Injectors under a series of model numbers, starting with 900103T. The device name is cut off partway through that list. The product code is DXT, angiographic injectors and syringes.
Class II, 21 CFR 870.1650. The General Hospital review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Fortis filed from Taoyuan City, Taiwan. Review took 265 calendar days (August 22, 2025 to May 14, 2026).
Clearance details
- Device name as filed
- 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
- Product code
- Product code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taoyuan City, TW
Recent devices under product code DXT
view all- K262043 — MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit +2 more
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.