Cleared Special

K123839 - WA SERIES: WA100

Also marketed or referenced as:
WA200 WD100 WE100, WF100 WB200

K123839 is an FDA 510(k) clearance for WA SERIES: WA100, manufactured by Ningbo Diaier Electronic Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 29-day FDA review.

K123839 · Ningbo Diaier Electronic Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
29d
Days
Class 2
Risk

K123839 is an FDA 510(k) clearance for the WA SERIES: WA100. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ningbo Diaier Electronic Co., Ltd. (Yuyao City, Zhejiang, CN). The FDA issued a Cleared decision on January 11, 2013 after a review of 29 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 Ningbo Diaier Electronic Co., Ltd. devices

FDA 510(k) Submission Details - K123839

510(k) Number K123839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date January 11, 2013
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 845
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K123839.
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
K120673 · Grandway Technology (Shenzhen) Limited · Feb 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
K120675 · Grandway Technology (Shenzhen) Limited · Feb 2013
COMPACT DIGITAL BLOOD PRESSURE MONITOR
K122810 · Thermor , Ltd. · Feb 2013
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K123669 · Zhongshan Transtek Electronics Co., Ltd. · Dec 2012
CARDIOSCOPE
K121266 · Pulsecor Limited · Dec 2012
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
K123446 · United States Gtm Medical Devices, Inc. · Dec 2012