Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhuzhou Goldenhot Medical Technology Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243085 | IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-12-21 | 82 | 0 |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 | 87 | 0 |
| K231613 | Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE0 | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2023-07-31 | 59 | 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