Cleared Traditional

Wrist Blood Pressure Monitor (OHMS11, OHMS12) (K242568) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242568 · Shenzhen Zhongkemingwang Telecommunications Software Corp. · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 285
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K242568.
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K241431 · Joytech Healthcare Co. , Ltd. · Jan 2025