Cleared Special

K093359 - 1103 DIGITAL BLOOD PRESSURE MONITOR

K093359 is the FDA 510(k) clearance for 1103 DIGITAL BLOOD PRESSURE MONITOR by Shanghai Little Doctor Co. Limited. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 30-day FDA review.

K093359 · Shanghai Little Doctor Co. Limited · Cardiovascular device
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Nov 2009
Decision
30d
Days
Class 2
Risk

K093359 is an FDA 510(k) clearance for the 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSU.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shanghai Little Doctor Co. Limited (Nantong, Jiangsu, CN). The FDA issued a Cleared decision on November 27, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shanghai Little Doctor Co. Limited devices

Submission Details

510(k) Number K093359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2009
Decision Date November 27, 2009
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 504
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K093359.
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911
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