FDA cleared the 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 from Fortis Biosolutions Company Limited on May 14, 2026 under K252652, a traditional 510(k). The device falls under product code DXT, Injector And Syringe, Angiographic, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Aug 22, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Fortis Biosolutions Company Limited in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K252652?
K252652 is the FDA 510(k) for 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, submitted by Fortis Biosolutions Company Limited. FDA's decision date was May 14, 2026, under product code DXT (Injector And Syringe, Angiographic).
Who makes the 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?
Fortis Biosolutions Company Limited, based in Taoyuan City, is the applicant of record for K252652.
How long did the K252652 review take?
FDA received the submission on Aug 22, 2025 and issued its decision on May 14, 2026, 265 days later.