Cleared Traditional

K052676 - KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

K052676 is an FDA 510(k) clearance for KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD ..., manufactured by Kodon(Tianjin)Electronic&Electrical Apparatus Co.,. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K052676 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
143d
Days
Class 2
Risk

K052676 is an FDA 510(k) clearance for the KD-322 SEMI 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 February 17, 2006 after a review of 143 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.

FDA 510(k) Submission Details - K052676

510(k) Number K052676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date February 17, 2006
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
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 1213
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K052676.
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K052450 · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Feb 2006
MARCH HEALTHCARE HEALTH MONITORING KIT
K060194 · March Healthcare Corporation · Feb 2006
HOCA EZ-CARE BP108, TENDER-CARE BP109
K052671 · Hoca Medical Microsystem, Inc. · Feb 2006
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
K053185 · Medwave, Inc. · Jan 2006
K052676 · KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Download PDF FDA Summary Kodon(Tianjin)Electro…