510(k) Report

FDA applicant

Global Medikit Limited

Dehradun, IN2 decisions2020–20220 recalls

FDA records 2 decisions for Global Medikit Limited (Dehradun, IN) from 2020 to 2022: 2 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Global Medikit Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12022: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Global Medikit Limited by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Global Medikit Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022
  • K193158ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020

All 2 as Global Medikit Limited →