Cleared Traditional

K170454 - Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U

K170454 is an FDA 510(k) clearance for Automatic Blood Pressure Monitor Model ..., manufactured by Honsun (Nantong) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K170454 · Honsun (Nantong) Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
252d
Days
Class 2
Risk

K170454 is an FDA 510(k) clearance for the Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U. 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 25, 2017 after a review of 252 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

FDA 510(k) Submission Details - K170454

510(k) Number K170454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2017
Decision Date October 25, 2017
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 125d · This submission: 252d
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 Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 990
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K170454.
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
Electronic Blood Pressure Monitor
K170151 · Shenzhen Pango Electronic Co., Ltd. · Oct 2017
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
K172498 · Microlife Intellectual Property GmbH · Oct 2017
higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
K172739 · Higi Sh, LLC · Oct 2017