Cleared Traditional

K230145 - ONE-CUF (FDA 510(k) Clearance)

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

K230145 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device

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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.