510(k) Report

FDA applicant

Set Medikal Sanayi VE Ticaret Anonim Sirketi

Istanbul, TR2 decisions2020–20210 recalls

FDA records 2 decisions for Set Medikal Sanayi VE Ticaret Anonim Sirketi (Istanbul, TR) from 2020 to 2021: 2 510(k) clearances. All are in product code FMF (Syringe, Piston). Its devices cite 2 predicates, 1 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, general hospital panel, where it files most

How often FDA has decided Set Medikal Sanayi VE Ticaret Anonim Sirketi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 12021: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Set Medikal Sanayi VE Ticaret Anonim Sirketi by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for…Set Medikal Sanayi VE Ticaret Anonim Sirketi · 20202cite it

What has FDA decided for it lately?

  • K2102001 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-LockSet Medikal Sanayi VE Ticaret Anonim Sirketi · 2021
  • K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for…Set Medikal Sanayi VE Ticaret Anonim Sirketi · 2020

All 2 as Set Medikal Sanayi VE Ticaret Anonim Sirketi →