One-Cuf
FDA 510(k) K230145 · Ge Medical Systems Information Technologies, Inc.
510(k) numberK230145
Submission
- Device name
- One-Cuf
- Applicant
- Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US - Received
- January 18, 2023
- Decision date
- March 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXQ – Blood Pressure Cuff
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1120
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code DXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure CuffDXQ · Traditional | Medline Industries, LP | 06/22/2026SE |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ · Traditional | Nihon Kohden Corporation | 05/06/2026SE |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122…DXQ · Traditional | Shenzhen Best Electronics Co., Ltd. | 02/13/2026SE |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special | Unimed Medical Supplies, Inc. | 01/09/2026SE |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | Baxter Healthcare Corporation | 12/16/2025SE |
| K250765 | AViTA Arm Type Blood Pressure Monitor CuffDXQ · Traditional | Avita Corporation | 09/03/2025SE |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional | Unimed Medical Supplies, Inc. | 07/15/2025SE |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuffDXQ · Traditional | Shenzhen Medke Technology Co., Ltd. | 10/31/2024SE |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid SphygmomanometerDXQ · Traditional | Wenzhou Longwan Medical Device Factory | 03/20/2024SE |
| K233276 | Reusable Blood Pressure CuffDXQ · Traditional | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 12/21/2023SE |
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| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | 07/09/2025SE |
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| K233810 | Portrait VSMMWI · Traditional | 04/25/2024SE |
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| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK · Traditional | 12/13/2023SE |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services…MWI · Traditional | 08/11/2023SE |
| K222586 | Mural Clinical ViewerMHX · Traditional | 12/21/2022SE |
| K221904 | EK12 V2 AlgorithmMHX · Traditional | 12/20/2022SE |
Questions and answers
When was One-Cuf cleared by the FDA?
One-Cuf (K230145) received a 510(k) decision of Substantially Equivalent on March 14, 2023, 55 days after the submission was received.
What is the product code of K230145?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.