Cleared Traditional

K222887 - Arm Blood Pressure Monitor/Automatic Wi...

K222887 is an FDA 510(k) clearance for Arm Blood Pressure Monitor/Automatic Wi..., manufactured by Famidoc Technology Company Limited. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K222887 · Famidoc Technology Company Limited · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
199d
Days
Class 2
Risk

K222887 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Famidoc Technology Company Limited (Dongguan, CN). The FDA issued a Cleared decision on April 10, 2023 after a review of 199 days - an extended review 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: 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 Famidoc Technology Company Limited devices

FDA 510(k) Submission Details - K222887

510(k) Number K222887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2022
Decision Date April 10, 2023
Days to Decision 199 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
74d slower than avg
Panel avg: 125d · This submission: 199d
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 566
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K222887.
Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
K222926 · Shenzhen Yuezhongxing Technology Co., Ltd. · May 2023
CONNEQT PULSE
K221742 · Atcor Medical · Apr 2023
Task Force CORE
K223332 · Cnsystems Medizintechnik GmbH · Apr 2023
Electronic Sphygmomanometers
K222394 · Qingdao Yasee Medical Device Co., Ltd. · Mar 2023
Arm Blood Pressure Monitor
K222869 · Andon Health Co, Ltd. · Feb 2023
Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
K222153 · Microlife Intellectual Property GmbH · Feb 2023