Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hironic Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
288 daysmedian FDA review time
507 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 | 59 | 0 |
| K251334 | NEW DOUBLO 2.0 | Hironic Co., Ltd. | 2025-09-29 | 152 | 0 |
| K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024-11-08 | 200 | 0 |
| K233123 | SILKRO | Hironic Co., Ltd. | 2024-06-24 | 271 | 0 |
| K210084 | SILKRO | Hironic Co., Ltd. | 2022-06-03 | 507 | 0 |
| K201773 | PICOHI | Hironic Co., Ltd. | 2021-10-19 | 477 | 0 |
| K192970 | SLIMUS | Hironic Co., Ltd. | 2020-12-01 | 405 | 0 |
| K173676 | A-FIT | Hironic Co., Ltd. | 2018-09-14 | 288 | 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