Jeil Medical Corporation: FDA clearances and approvals
Jeil Medical Corporation has 53 FDA 510(k) clearances (first 2002, latest 2026), across 17 product codes in 3 review panels. Median 510(k) review time: 136 days. Since 2017 its median was 137 days, against 109 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 148 |
| 2013 | 3 | 121 |
| 2014 | 2 | 350 |
| 2015 | 3 | 160 |
| 2016 | 4 | 62 |
| 2017 | 8 | 164 |
| 2018 | 2 | 155 |
| 2019 | 2 | 97 |
| 2020 | 3 | 69 |
| 2021 | 1 | 154 |
| 2022 | 2 | 122 |
| 2023 | 3 | 60 |
| 2024 | 3 | 90 |
| 2025 | 6 | 134 |
| 2026 | 1 | 258 |
Review time against the same product codes
Since 2017, Jeil Medical Corporation's cleared 510(k)s took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 24 | 24 |
| JEY | Plate, Bone | 6 | 6 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
Plus 7 more product codes.
Review panels
- Orthopedic (40)
- Dental (9)
- Neurology (4)
Most recent Jeil Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252246 | Leforte MMF System | JEY | 2026-04-02 | 258 |
| K252826 | ARIX Femur Nail System | HSB | 2025-12-10 | 96 |
| K251431 | FIX-C PEEK ACIF SA System | OVE | 2025-06-27 | 50 |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | MAX | 2025-06-12 | 171 |
| K242751 | ARIX Pectus Bar System | HRS | 2025-05-30 | 260 |
| K242247 | ARIX Femur Nail System | HSB | 2025-04-22 | 265 |
| K243915 | FIX-C 3D Ti ACIF System | ODP | 2025-02-18 | 60 |
| K243004 | Xpine Spinal Fixation System | NKB | 2024-11-08 | 43 |
| K231251 | FlexWing Anterior Cervical Plate System | KWQ | 2024-07-24 | 450 |
| K233912 | ARIX Cannulated Screw System | HWC | 2024-03-11 | 90 |
43 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jeil Medical Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Jeil Medical Corporation have?
Jeil Medical Corporation has 53 FDA 510(k) clearances (first 2002, latest 2026), across 17 product codes in 3 review panels.
How long does FDA take to clear Jeil Medical Corporation's 510(k)s?
The median time from FDA receipt to decision across Jeil Medical Corporation's cleared 510(k)s is 136 days. Since 2017: 137 days, versus 109 days for all cleared 510(k)s in the same product codes.
What devices does Jeil Medical Corporation make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 24); JEY (Plate, Bone, 6); HWC (Screw, Fixation, Bone, 4).
Has Jeil Medical Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Jeil Medical Corporation. Related entities may recall under other names.
Next steps
- See all 53 Jeil Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code HRS, Jeil Medical Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.