Ceragem Co., Ltd.: FDA clearances and approvals
Ceragem Co., Ltd. has 7 FDA 510(k) clearances (first 2004, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time: 162 days. Since 2017 its median was 136 days, against 166 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 192 |
| 2022 | 1 | 109 |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 2 | 102 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ceragem Co., Ltd.'s cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JFB | Table, Physical Therapy, Multi Function | 7 | 7 |
Review panels
Most recent Ceragem Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) | JFB | 2025-07-11 | 162 |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) | JFB | 2025-01-08 | 43 |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) | JFB | 2024-11-27 | 29 |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | JFB | 2022-06-17 | 109 |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | JFB | 2021-03-18 | 169 |
| K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901 | JFB | 2021-03-02 | 215 |
| K040031 | CERAGEM-C THERMAL ACUPRESSURE MASSAGER | JFB | 2004-07-28 | 202 |
Recalls
openFDA lists no recalls under a recalling firm named Ceragem Co., Ltd..
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 Ceragem Co., Ltd. have?
Ceragem Co., Ltd. has 7 FDA 510(k) clearances (first 2004, latest 2025), across 1 product code in 1 review panel.
How long does FDA take to clear Ceragem Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ceragem Co., Ltd.'s cleared 510(k)s is 162 days. Since 2017: 136 days, versus 166 days for all cleared 510(k)s in the same product codes.
What devices does Ceragem Co., Ltd. make?
Its most frequent FDA product codes are JFB (Table, Physical Therapy, Multi Function, 7).
Has Ceragem Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ceragem Co., Ltd. Related entities may recall under other names.
Next steps
- See all 7 Ceragem Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JFB, Ceragem Co., Ltd.'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.