Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Takara Belmont USA, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
475 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102456 | INTRAORAL BELSENSOR GOLD | Takara Belmont USA, Inc. | 2011-12-15 | 475 | 0 |
| K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | Takara Belmont USA, Inc. | 2007-12-20 | 127 | 0 |
| K062529 | BELMAX CM MODEL X168 | Takara Belmont USA, Inc. | 2006-10-05 | 37 | 0 |
| K041834 | ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CAL | Takara Belmont USA, Inc. | 2004-12-03 | 149 | 0 |
| K042260 | PHOT-X II, MODEL 303 | Takara Belmont USA, Inc. | 2004-09-07 | 15 | 0 |
| K040748 | ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM | Takara Belmont USA, Inc. | 2004-06-02 | 71 | 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