Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ito Co., Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
224 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203525 | D function | Ito Co., Ltd. | 2021-05-05 | 155 | 0 |
| K112520 | US-101L, US-103S | Ito Co., Ltd. | 2011-10-26 | 56 | 0 |
| K081943 | MODEL ES-130 | Ito Co., Ltd. | 2008-11-24 | 139 | 0 |
| K081247 | TM-400 | Ito Co., Ltd. | 2008-08-25 | 116 | 0 |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | Ito Co., Ltd. | 2003-10-09 | 30 | 0 |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Ito Co., Ltd. | 2003-01-28 | 154 | 0 |
| K990787 | TRIO 300 | Ito Co., Ltd. | 1999-10-20 | 224 | 0 |
| K992545 | TM-300 TRACTION SYSTEM | Ito Co., Ltd. | 1999-09-01 | 33 | 1 |
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