Cleared Traditional

K070825 - LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR

K070825 is an FDA 510(k) clearance for LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR, manufactured by Little Doctor (Shanghai) Electronic Manufacturing. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K070825 · Little Doctor (Shanghai) Electronic Manufacturing · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2007
Decision
60d
Days
Class 2
Risk

K070825 is an FDA 510(k) clearance for the LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Little Doctor (Shanghai) Electronic Manufacturing (Shanghai, CN). The FDA issued a Cleared decision on May 25, 2007 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Little Doctor (Shanghai) Electronic Manufacturing devices

FDA 510(k) Submission Details - K070825

510(k) Number K070825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date May 25, 2007
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 894
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K070825.
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SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
K070086 · Sensacare , Ltd. · May 2007