# Tsk Laboratory, Japan

- Location (FDA's records): Tochigi-Ken, JP
- FDA decisions: 4 (1997–2026): 4 510(k) clearances
- Product codes: FMI (2), QNQ (1), QYM (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Poonglim Pharmatech, Inc.: 2 (https://510kreport.com/company/poonglim-pharmatech)

## Firms that cite its devices most
- Ocujet, LLC: 1 (https://510kreport.com/company/ocujet)
- Altaviz, LLC: 1 (https://510kreport.com/company/altaviz)
- Tsk Laboratory International Japan KK: 1 (https://510kreport.com/company/tsk-laboratory-international-japan)

## Its most-cited devices
- K970370: TSK Sterijekt Premium Disposable Hypodermic Needle (1997), cited by 3

## Recent decisions
- K262516: TSK OptiXion (Oct 6, 2026)
- K250127: TSK Syringe (Jul 30, 2025)
- K250284: TSK SELECT™ Needle (Jul 24, 2025)
- K970370: TSK Sterijekt Premium Disposable Hypodermic Needle (Apr 10, 1997)

Source page: https://510kreport.com/company/tsk-laboratory-japan