Cleared Traditional

K070828 - KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD...

K070828 is the FDA 510(k) clearance for KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD... by Kodon(Tianjin)Electronic&Electrical Apparatus Co.,. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K070828 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
142d
Days
Class 2
Risk

K070828 is an FDA 510(k) clearance for the KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Kodon(Tianjin)Electronic&Electrical Apparatus Co., (Tianjin, CN). The FDA issued a Cleared decision on August 15, 2007 after a review of 142 days - within the typical 510(k) review window.

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 Kodon(Tianjin)Electronic&Electrical Apparatus Co., devices

Submission Details

510(k) Number K070828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date August 15, 2007
Days to Decision 142 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 125d · This submission: 142d
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 509
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