Cleared Traditional

K183535 - Fully Automatic Electronic Blood Pressu...

K183535 is the FDA 510(k) clearance for Fully Automatic Electronic Blood Pressu... by Andon Health Co, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K183535 · Andon Health Co, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
167d
Days
Class 2
Risk

K183535 is an FDA 510(k) clearance for the Fully Automatic Electronic Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on June 4, 2019 after a review of 167 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 Andon Health Co, Ltd. devices

Submission Details

510(k) Number K183535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2018
Decision Date June 04, 2019
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
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 500
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K183535.
Oscillometric Blood Pressure Monitor
K190927 · Rudolf Riester GmbH · Jun 2019
The ClearSight finger cuffs
K190130 · Edwards Lifesciences, LLC · Jun 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
K190133 · Health & Life Co., Ltd. · Jun 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
K190134 · Health & Life Co., Ltd. · May 2019
Tel-O-Graph
K173895 · I.E.M. Industrielle Entwicklung and Medizintechnik · May 2019
Fully Automatic Electronic Blood Pressure Monitor
K183534 · Andon Health Co, Ltd. · May 2019