510(k) Report

FDA applicant

Chirana T. Injecta

Stará Turá, SK6 decisions2021–20260 recalls

FDA records 6 decisions for Chirana T. Injecta (Stará Turá, SK) from 2021 to 2026: 6 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 211 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Chirana T.Injecta,A.S.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Chirana T. Injecta’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12022: 22024: 12026 (partial year): 2
2021high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Chirana T. Injecta by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston3decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • FMINeedle, Hypodermic, Single Lumen1decision
  • PNREnteral Syringes With Enteral Specific Connectors1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 269 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 211 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201044CHIRANA Insulin SyringesChirana T. Injecta · 20221cites it

What has FDA decided for it lately?

  • K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S. · 2026
  • K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S. · 2026
  • K242434Insulin SyringesChirana T. Injecta · 2024
  • K220614MEDOJECT fine Pen NeedlesChirana T. Injecta · 2022
  • K201044CHIRANA Insulin SyringesChirana T. Injecta · 2022
  • K201009CHIRAVAC Blood Collection NeedlesChirana T. Injecta · 2021

All 4 as Chirana T. Injecta →All 2 as Chirana T.Injecta,A.S. →