Cleared Traditional

Arm Blood Pressure Monitor (K193456) - FDA 510(k) Clearance

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

K193456 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
216d
Days
Class 2
Risk

K193456 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ningbo Ranor Medical Science & Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on July 16, 2020 after a review of 216 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 Ningbo Ranor Medical Science & Technology Co., Ltd. devices

Submission Details

510(k) Number K193456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2019
Decision Date July 16, 2020
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
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

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 273
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K193456.
Electronic Blood Pressure Monitor
K200939 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Aug 2020
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K200649 · Joytech Healthcare Co. , Ltd. · Aug 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200738 · Microlife Intellectual Property GmbH · Jul 2020
Automatic Upper Arm Blood Pressure Monitor
K193627 · Dongguan E-Test Technology Co., Ltd. · Jul 2020
AGE Automatic Wrist Blood Pressure Monitor
K193628 · Dongguan E-Test Technology Co., Ltd. · Jul 2020
Automatic Upper Arm Blood Pressure Monitor
K193624 · Dongguan E-Test Technology Co., Ltd. · Jul 2020