Cleared Traditional

Automatic Blood Pressure Monitor Model LD-518 & LD-537 (K170466) - FDA 510(k) Clearance

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

K170466 · Honsun (Nantong) Co., Ltd. · Cardiovascular device
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Oct 2017
Decision
254d
Days
Class 2
Risk

K170466 is an FDA 510(k) clearance for the Automatic Blood Pressure Monitor Model LD-518 & LD-537. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Honsun (Nantong) Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on October 27, 2017 after a review of 254 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 Honsun (Nantong) Co., Ltd. devices

Submission Details

510(k) Number K170466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2017
Decision Date October 27, 2017
Days to Decision 254 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 125d · This submission: 254d
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 280
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K170466.
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
K170866 · Honsun (Nantong) Co., Ltd. · Feb 2018
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