Cleared Traditional

K230145 - ONE-CUF

K230145 is the FDA 510(k) clearance for ONE-CUF by Ge Medical Systems Information Technologies, Inc.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K230145 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
55d
Days
Class 2
Risk

K230145 is an FDA 510(k) clearance for the ONE-CUF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on March 14, 2023 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems Information Technologies, Inc. devices

Submission Details

510(k) Number K230145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2023
Decision Date March 14, 2023
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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

GE Healthcare
Michelle Johnson

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 - DXQ Blood Pressure Cuff

All 73
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K230145.
Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2)
K232772 · Shenzhen Plinma Technology Co. , Ltd. · Nov 2023
NIBPCuff
K231961 · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 2023
Aneroid Sphygmomanometer
K230859 · Wenzhou Kangshun Medical Devices Co.,Ltd · Jun 2023
Aneroid Sphygmomanometer
K222652 · Cardicare Company, Ltd. · Nov 2022
Disposable Blood Pressure Cuff
K222420 · Wenzhou Xikang Medical Instruments Co., Ltd. · Nov 2022
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
K221857 · Zhejiang Lude Technology Development Co., Ltd. · Oct 2022