Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangdong Genial Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
205 daysmedian FDA review time
268 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 | 268 | 0 |
| K232678 | Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. | 2024-01-31 | 152 | 0 |
| K231250 | Digital Blood Pressure Monitor | Guangdong Genial Technology Co., Ltd. | 2023-11-28 | 211 | 0 |
| K231245 | Digital Blood Pressure Monitor (Arm Type) | Guangdong Genial Technology Co., Ltd. | 2023-11-22 | 205 | 0 |
| K231243 | Finger Clip Pulse Oximeter | Guangdong Genial Technology Co., Ltd. | 2023-10-31 | 183 | 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