510(k) Report

FDA applicant

Bahadir USA Corp.

Lindenhurst, NY4 decisions2010–20241 recall

FDA records 4 decisions for Bahadir USA Corp. (Lindenhurst, NY) from 2010 to 2024: 4 510(k) clearances. All are in product code KCT (Sterilization Wrap Containers, Trays…). Its devices cite 10 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Bahadir USA, LLC”.

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 Bahadir USA Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010: 12012: 12014: 12024: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2010high 1 (2014) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Bahadir USA Corp. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories4decisions

Whose devices does it build on?

Its devices cite 10 predicates; 4 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.

  • K102146Bahadir Sterilization TraysBahadir USA Corp. · 20102cite it
  • K131407Bahadir Sterilization TraysBahadir USA Corp. · 20141cites it
  • K112090Bahadir Sterilization TraysBahadir USA Corp. · 20121cites it

What has FDA decided for it lately?

  • K233578Bahadir Sterilization ContainersBahadir USA, LLC · 2024
  • K131407Bahadir Sterilization TraysBahadir USA Corp. · 2014
  • K112090Bahadir Sterilization TraysBahadir USA Corp. · 20121 recall
  • K102146Bahadir Sterilization TraysBahadir USA Corp. · 20101 recall

All 3 as Bahadir USA Corp. →The one decision as Bahadir USA, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K102146Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿…Jul 30, 2014Class II