Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ceragem Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
215 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) | Ceragem Co., Ltd. | 2025-07-11 | 162 | 0 |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-230 | Ceragem Co., Ltd. | 2025-01-08 | 43 | 0 |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) | Ceragem Co., Ltd. | 2024-11-27 | 29 | 0 |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM | Ceragem Co., Ltd. | 2022-06-17 | 109 | 0 |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-M | Ceragem Co., Ltd. | 2021-03-18 | 169 | 0 |
| K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901 | Ceragem Co., Ltd. | 2021-03-02 | 215 | 0 |
| K040031 | CERAGEM-C THERMAL ACUPRESSURE MASSAGER | Ceragem Co., Ltd. | 2004-07-28 | 202 | 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