Cleared Traditional

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)) (K243115) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243115 · Shenzhen Urion Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
144d
Days
Class 2
Risk

K243115 is an FDA 510(k) clearance for the Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U8.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen Urion Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 21, 2025 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Urion Technology Co., Ltd. devices

Submission Details

510(k) Number K243115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date February 21, 2025
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 269
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K243115.
Arm Blood Pressure Monitor (ARM-30H)
K250116 · Shenzhen AOJ Medical Technology Co., Ltd. · Apr 2025
Globalcare Blood Pressure Monitor (GUS610)
K250136 · Globalcare Medical Technology Co., Ltd. · Apr 2025
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
K250091 · Korot Co., Ltd. · Mar 2025
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
K241578 · Shenzhen Bsx Technology Electronics Co., Ltd. · Feb 2025
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
K241634 · Guangdong Xinyu Electronic and Technology Co., Ltd. · Feb 2025
Electronic Blood Pressure Monitor
K243661 · Hetaida Technology Co., Ltd. · Feb 2025