Cleared Traditional

K170497 - V10

K170497 is an FDA 510(k) clearance for V10, manufactured by Mediana Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K170497 · Mediana Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
301d
Days
Class 2
Risk

K170497 is an FDA 510(k) clearance for the V10. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Mediana Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on December 15, 2017 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mediana Co., Ltd. devices

FDA 510(k) Submission Details - K170497

510(k) Number K170497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2017
Decision Date December 15, 2017
Days to Decision 301 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
176d slower than avg
Panel avg: 125d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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

International Regulatory Consulatants
Charlie Mack

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 843
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K170497.
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
K170866 · Honsun (Nantong) Co., Ltd. · Feb 2018
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312
K172896 · Shenzhen Jiacom Technology CO ., Ltd. · Jan 2018
Digital Blood Pressure Monitor-Wrist Style
K171833 · Shenzhen Combei Technology Co., Ltd. · Jan 2018
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
K170666 · Joytech Healthcare Co. , Ltd. · Nov 2017
Automatic Wrist Bluetooth Blood Pressure Monitor
K170545 · Truly Instrument , Ltd. · Nov 2017
Automatic Blood Pressure Monitor Model LD-518 & LD-537
K170466 · Honsun (Nantong) Co., Ltd. · Oct 2017