Cleared Traditional

K061279 - LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

K061279 is an FDA 510(k) clearance for LD-578 FULLY AUTOMATIC DIGITAL BLOOD PR..., manufactured by Little Doctor (Shanghai) Electronic. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K061279 · Little Doctor (Shanghai) Electronic · Cardiovascular device
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Aug 2006
Decision
102d
Days
Class 2
Risk

K061279 is an FDA 510(k) clearance for the LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Little Doctor (Shanghai) Electronic (Great Neck, US). The FDA issued a Cleared decision on August 18, 2006 after a review of 102 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 Little Doctor (Shanghai) Electronic devices

FDA 510(k) Submission Details - K061279

510(k) Number K061279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2006
Decision Date August 18, 2006
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
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 904
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FUSION
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