510(k) Report

FDA applicant

T&R BIOFAB CO., Ltd.

Siheung-Si, KR2 decisions2023–20260 recalls

FDA records 2 decisions for T&R BIOFAB CO., Ltd. (Siheung-Si, KR) from 2023 to 2026: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and GXP (Methyl Methacrylate For Cranioplasty). 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, general hospital panel, where it files most

How often FDA has decided T&R BIOFAB CO., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 12026 (partial year): 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — T&R BIOFAB CO., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FLLContinuous Measurement Thermometer1decision
  • GXPMethyl Methacrylate For Cranioplasty1decision

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?

  • K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd. · 2026
  • K222057ThermoclickT&R BIOFAB CO., Ltd. · 2023

All 2 as T&R BIOFAB CO., Ltd. →