Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jpi Healthcare Co, Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
605 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260482 | DRE Duo | Jpi Healthcare Co, Ltd. | 2026-06-15 | 122 | 0 |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | 2025-02-24 | 60 | 0 |
| K213057 | ExamVue Duo | Jpi Healthcare Co, Ltd. | 2022-02-18 | 149 | 0 |
| K142930 | Exam Vue DR | Jpi Healthcare Co, Ltd. | 2015-04-17 | 190 | 0 |
| K102327 | CLEARVISION DR 7000F | Jpi Healthcare Co, Ltd. | 2012-04-13 | 605 | 0 |
| K101779 | CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM | Jpi Healthcare Co, Ltd. | 2011-05-16 | 325 | 0 |
| K955706 | JPI AUTOMATIC X-RAY FILM PROCESSOR | Jpi Healthcare Co, Ltd. | 1996-02-12 | 59 | 0 |
| K954161 | JPI INTENSIFYING SCREEN | Jpi Healthcare Co, Ltd. | 1996-02-02 | 150 | 0 |
| K950043 | JPI AUTOMATIC X-RAY FILM PROCESSOR | Jpi Healthcare Co, Ltd. | 1995-05-10 | 125 | 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