Cleared Traditional

K100740 - MD2000B VITAL SIGN MONITOR

K100740 is the FDA 510(k) clearance for MD2000B VITAL SIGN MONITOR by Beijing Choice Electronic Technololgy Co., Ltd.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K100740 · Beijing Choice Electronic Technololgy Co., Ltd. · Cardiovascular device
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Jul 2010
Decision
115d
Days
Class 2
Risk

K100740 is an FDA 510(k) clearance for the MD2000B VITAL SIGN MONITOR, MODEL MD2000B. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technololgy Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 9, 2010 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Beijing Choice Electronic Technololgy Co., Ltd. devices

Submission Details

510(k) Number K100740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2010
Decision Date July 09, 2010
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 148
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