510(k) Report

FDA applicant

Tsk Laboratory International Japan KK

Tochigi-Shi, JP2 decisions2024–20240 recalls

FDA records 2 decisions for Tsk Laboratory International Japan KK (Tochigi-Shi, JP) in 2024: 2 510(k) clearances. Most are in product codes QNS (Low Dead Space Needle, Single Lumen, Hypodermic) and QYM (Ophthalmic Needle). Its devices cite 3 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 Tsk Laboratory International Japan KK’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2024: 2
2024high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Tsk Laboratory International Japan KK by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QNSLow Dead Space Needle, Single Lumen, Hypodermic1decision
  • QYMOphthalmic Needle1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK · 2024
  • K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK · 2024

All 2 as Tsk Laboratory International Japan KK →