Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tsk Laboratory, Japan — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250127 | TSK Syringe | Tsk Laboratory, Japan | 2025-07-30 | 194 | 0 |
| K250284 | TSK SELECTâ„¢ Needle | Tsk Laboratory, Japan | 2025-07-24 | 174 | 0 |
| K970370 | TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE | Tsk Laboratory, Japan | 1997-04-10 | 69 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda