Cleared Traditional

K222160 - GUS610 Blood pressure monitor

K222160 is an FDA 510(k) clearance for GUS610 Blood pressure monitor, manufactured by Globalcare Medical Technology Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K222160 · Globalcare Medical Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
125d
Days
Class 2
Risk

K222160 is an FDA 510(k) clearance for the GUS610 Blood pressure monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Globalcare Medical Technology Co., Ltd. (Zhongshan City, CN). The FDA issued a Cleared decision on November 22, 2022 after a review of 125 days - within the typical 510(k) review window.

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 Globalcare Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K222160

510(k) Number K222160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2022
Decision Date November 22, 2022
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
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 Consultant

Donawa Lifescience Consluting Srl
Roger Gray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 565
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K222160.
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
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G
K222125 · Shenzhen AOJ Medical Technology Co., Ltd. · Dec 2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
K221833 · Edwards Lifesciences, LLC · Nov 2022
YUWELL Electronic Blood Pressure Monitor
K221372 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Oct 2022
Arm Blood Pressure Monitor
K221913 · Alicn Medical (Shenzhen), Inc. · Oct 2022