510(k) Report

FDA applicant

Tbm Corporation

Gwangju, KR2 decisions2019–20220 recalls

FDA records 2 decisions for Tbm Corporation (Gwangju, KR) from 2019 to 2022: 2 510(k) clearances. All are in product code OLR (Oral Wound Dressing). 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

How often FDA has decided Tbm Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12022: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Tbm Corporation by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLROral Wound Dressing2decisions

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K211851Ora-AidTbm Corporation · 20221cites it
  • K183436OraCureTbm Corporation · 20191cites it

What has FDA decided for it lately?

  • K211851Ora-AidTbm Corporation · 2022
  • K183436OraCureTbm Corporation · 2019

All 2 as Tbm Corporation →