One-Cuf
by GE Medical Systems Information Technologies, Inc.
510(k) K230145
One-Cuf is a Class II device made by GE Medical Systems Information Technologies, Inc., cleared under FDA 510(k) K230145 on 14 Mar 2023, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230145 | Date14 Mar 2023 | StatusActive |
Official records
- FDA 510(k) database K230145
Recalls
-
- Ongoing Z-2027-2024
Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Timeline
- Cleared FDA 510(k) K230145
- Recall initiated FDA recalls Z-2027-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXQ
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1120
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K230145
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ONE-CUF ONE-A1-1B | ONE-A1-1B | 00195278571342 | — | No longer on the market |
| ONE-CUF ONE-A1-2A | ONE-A1-2A | 00195278571380 | — | No longer on the market |
| ONE-CUF ONE-A2-1B | ONE-A2-1B | 00195278571410 | — | No longer on the market |
| ONE-CUF ONE-A2-1B-L | ONE-A2-1B-L | 00195278571458 | — | No longer on the market |
| ONE-CUF ONE-A2-2A | ONE-A2-2A | 00195278571397 | — | No longer on the market |
| ONE-CUF ONE-A2-2A-L | ONE-A2-2A-L | 00195278571366 | — | No longer on the market |
| ONE-CUF ONE-A3-1B | ONE-A3-1B | 00195278571595 | — | No longer on the market |
| ONE-CUF ONE-A3-2A | ONE-A3-2A | 00195278571588 | — | No longer on the market |
| ONE-CUF ONE-P1-1B | ONE-P1-1B | 00195278571359 | — | No longer on the market |
| ONE-CUF ONE-P1-2A | ONE-P1-2A | 00195278571403 | — | No longer on the market |
| ONE-CUF ONE-P2-1B | ONE-P2-1B | 00195278571373 | — | No longer on the market |
| ONE-CUF ONE-P2-2A | ONE-P2-2A | 00195278571427 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code DXQ (Blood Pressure Cuff).
- Welch Allyn, Inc. 901041 DS45 by Welch Allyn, Inc.
- NIBP Neo #1 Cuff 3.1 - 5.7 cm 2870181 by Draeger Medical Systems, Inc.
- Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M by Philips Medical Systems
- Medline Reusable Blood Pressure Cuff by MEDLINE INDUSTRIES, INC.
- Welch Allyn, Inc. 901040 7670-01S by Welch Allyn, Inc.
- CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER by Cypress Medical Products, Ltd.
- CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE by CAREMATE MEDICAL DEVICE CO., LTD
- NIBP Neo #2 Cuff 4.3 - 8 cm 2870199 by Draeger Medical Systems, Inc.
- Aneroid Type Blood Pressure Kit by Dongguan Mars Medical Products Co., Ltd.
- BLOOD PRESSURE SLEEVE W/TUBING by Devcom, Inc.
Other devices from GE Medical Systems Information Technologies, Inc.
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