Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jkh Health Co., Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
599 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | 2025-10-24 | 29 | 0 |
| K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025-06-04 | 439 | 0 |
| K240986 | Cold Compression | Jkh Health Co., Ltd. | 2024-05-01 | 21 | 0 |
| K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024-02-23 | 52 | 0 |
| K223541 | Cold/Hot Compression | Jkh Health Co., Ltd. | 2023-10-27 | 336 | 0 |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH- | Jkh Health Co., Ltd. | 2022-11-28 | 599 | 0 |
| K202839 | Overlapped Compression Therapy | Jkh Health Co., Ltd. | 2021-01-21 | 118 | 0 |
| K200561 | StimPlus Patch, StimPlus Patch, StimPlus Patch | Jkh Health Co., Ltd. | 2020-07-01 | 119 | 0 |
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017-04-14 | 217 | 0 |
| K153520 | Electronic Pulse Stimulator | Jkh Health Co., Ltd. | 2016-05-05 | 149 | 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