Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Urion Technology Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
284 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 | 148 | 0 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series mod | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 | 56 | 0 |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM6 | Shenzhen Urion Technology Co., Ltd. | 2025-04-25 | 105 | 0 |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (mo | Shenzhen Urion Technology Co., Ltd. | 2025-02-21 | 144 | 0 |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliB | Shenzhen Urion Technology Co., Ltd. | 2024-10-24 | 195 | 0 |
| K200802 | Infrared Thermometer | Shenzhen Urion Technology Co., Ltd. | 2020-10-07 | 194 | 0 |
| K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | Shenzhen Urion Technology Co., Ltd. | 2016-04-22 | 108 | 0 |
| K141683 | ELECTRONIC BLOOD PRESSURE MONITOR | Shenzhen Urion Technology Co., Ltd. | 2015-04-03 | 284 | 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