Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
FDA 510(k) clearance K260273 · decided 2026-03-26
Clearance details
- K-number
- K260273
- Device name
- Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
- Applicant
- Shenzhen Urion Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-01-29
- Decision date
- 2026-03-26
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Shenzhen Urion Technology Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.