510(k) Report

FDA applicant

Tsk Laboratory, Japan

Tochigi-Ken, JP4 decisions1997–20261 recall

FDA records 4 decisions for Tsk Laboratory, Japan (Tochigi-Ken, JP) from 1997 to 2026: 4 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and QNQ (Low Dead Space Piston Syringe). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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, Japan’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 22026 (partial year): 1
2007high 2 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tsk Laboratory, Japan by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tsk Laboratory, Japan’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?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • QNQLow Dead Space Piston Syringe1decision
  • QYMOphthalmic Needle1decision

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 3 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.

  • K970370TSK Sterijekt Premium Disposable Hypodermic NeedleTsk Laboratory, Japan · 19973cite it

What has FDA decided for it lately?

  • K262516TSK OptiXionTsk Laboratory, Japan · 2026
  • K250127TSK SyringeTsk Laboratory, Japan · 2025
  • K250284TSK SELECT™ NeedleTsk Laboratory, Japan · 2025
  • K970370TSK Sterijekt Premium Disposable Hypodermic NeedleTsk Laboratory, Japan · 19971 recall

All 4 as Tsk Laboratory, Japan →

What has been recalled?

1 recall linked to its devices; the latest:

  • K970370MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20…Dec 16, 2011