Shenzhen Urion Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Shenzhen Urion Technology Co., Ltd.” (first 2015, latest 2026), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 146 days. Since 2017 the median was 146 days, against 173 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 284 |
| 2016 | 1 | 108 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 194 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 195 |
| 2025 | 2 | 124 |
| 2026 | 2 | 102 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Urion Technology Co., Ltd. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 173 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 6 | 6 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
Review panels
- Cardiovascular (6)
- General Hospital (1)
- Physical Medicine (1)
Most recent Shenzhen Urion Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | DXN | 2026-05-14 | 148 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | DXN | 2026-03-26 | 56 |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | IRP | 2025-04-25 | 105 |
| K243115 | Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) | DXN | 2025-02-21 | 144 |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | DXN | 2024-10-24 | 195 |
| K200802 | Infrared Thermometer | FLL | 2020-10-07 | 194 |
| K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | 2016-04-22 | 108 |
| K141683 | ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2015-04-03 | 284 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Urion Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (160 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Urion Technology Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Shenzhen Urion Technology Co., Ltd.” (first 2015, latest 2026), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Urion Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Urion Technology Co., Ltd. is 146 days. Since 2017: 146 days, versus 173 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Urion Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 6); FLL (Continuous Measurement Thermometer, 1); IRP (Massager, Powered Inflatable Tube, 1).
Next steps
- See all 8 Shenzhen Urion Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Shenzhen Urion Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.