Cleared Traditional

Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (K241007) - FDA 510(k) Clearance

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

K241007 · Shenzhen Urion Technology Co., Ltd. · Cardiovascular device
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Oct 2024
Decision
195d
Days
Class 2
Risk

K241007 is an FDA 510(k) clearance for the Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01). 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 October 24, 2024 after a review of 195 days - an extended review cycle.

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 K241007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2024
Decision Date October 24, 2024
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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 Consultant

Shenzhen Reanny Medical Devices Management Consulting Co.,Lt
Wang Reanny

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K241007.
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
K241431 · Joytech Healthcare Co. , Ltd. · Jan 2025
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K242528 · Shenzhen Ruiankang Technology Co., Ltd. · Jan 2025
Arm Blood Pressure Monitor (model: BPM-A7VL)
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Arm Type Blood Pressure Monitor (BPM82)
K242193 · Avita Corporation · Oct 2024
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
K241613 · Shenzhen Hbcare Technology Co.,Ltd · Oct 2024
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
K242721 · Shenzhen Finicare Co., Ltd. · Oct 2024