Cleared Traditional

K242568 - Wrist Blood Pressure Monitor (OHMS11

K242568 is an FDA 510(k) clearance for Wrist Blood Pressure Monitor (OHMS11, manufactured by Shenzhen Zhongkemingwang Telecommunications Software Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K242568 · Shenzhen Zhongkemingwang Telecommunications Software Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
154d
Days
Class 2
Risk

K242568 is an FDA 510(k) clearance for the Wrist Blood Pressure Monitor (OHMS11, OHMS12). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen Zhongkemingwang Telecommunications Software Corp. (Shenzhen, CN). The FDA issued a Cleared decision on January 30, 2025 after a review of 154 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 Shenzhen Zhongkemingwang Telecommunications Software Corp. devices

FDA 510(k) Submission Details - K242568

510(k) Number K242568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2024
Decision Date January 30, 2025
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
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 K242568.
Electronic Blood Pressure Monitor
K243661 · Hetaida Technology Co., Ltd. · Feb 2025
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
K242352 · Accurate Meditech, Inc. · Feb 2025
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
K241590 · Guangdong Xinyu Electronic and Technology Co., Ltd. · Feb 2025
Vios Monitoring System(TM) Model 2050
K241728 · Murata Vios, Inc. · Jan 2025
BB-613-BPM
K241066 · Biobeat Technologies , Ltd. · Jan 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
K241431 · Joytech Healthcare Co. , Ltd. · Jan 2025