Jpi Healthcare Co, Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Jpi Healthcare Co, Ltd.” (first 1995, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 150 days. Since 2017 the median was 122 days, against 41 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 605 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 190 |
| 2016 | 1 | 281 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 149 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 60 |
| 2026 | 1 | 122 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jpi Healthcare Co, Ltd. took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 41 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 4 | 4 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 3 | 3 |
| IXW | Processor, Radiographic-Film, Automatic | 2 | 2 |
| EAM | Screen, Intensifying, Radiographic | 1 | 1 |
Review panels
- Radiology (10)
Most recent Jpi Healthcare Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260482 | DRE Duo | KPR | 2026-06-15 | 122 |
| K244010 | ExamVue Apex | MQB | 2025-02-24 | 60 |
| K213057 | ExamVue Duo | KPR | 2022-02-18 | 149 |
| K160143 | ClearVision ExamVue Flat Panel Detector | MQB | 2016-10-28 | 281 |
| K142930 | Exam Vue DR | KPR | 2015-04-17 | 190 |
| K102327 | CLEARVISION DR 7000F | MQB | 2012-04-13 | 605 |
| K101779 | CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM | KPR | 2011-05-16 | 325 |
| K955706 | JPI AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1996-02-12 | 59 |
| K954161 | JPI INTENSIFYING SCREEN | EAM | 1996-02-02 | 150 |
| K950043 | JPI AUTOMATIC X-RAY FILM PROCESSOR | IXW | 1995-05-10 | 125 |
Recalls
openFDA lists no recalls under a recalling firm named Jpi Healthcare Co, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Jpi Healthcare Co, Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Jpi Healthcare Co, Ltd.” (first 1995, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jpi Healthcare Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jpi Healthcare Co, Ltd. is 150 days. Since 2017: 122 days, versus 41 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jpi Healthcare Co, Ltd.?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 4); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 3); IXW (Processor, Radiographic-Film, Automatic, 2).
Next steps
- See all 10 Jpi Healthcare Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Jpi Healthcare Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.