Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos.
FDA 510(k) K844988 · Ethox Corp.
510(k) numberK844988
Submission
- Device name
- Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos.
- Applicant
- Ethox Corp.
Buffalo, NY, US - Received
- December 26, 1984
- Decision date
- April 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K040286 | Ethox Surgi-Cuf Adult Disposable Blood Pressure CuffsDXQ · Abbreviated | 03/15/2004SE |
| K031195 | Cuf-Cover (TM)DXQ · Traditional | 10/10/2003SE |
| K962850 | Tum-E-VacKDH · Traditional | 02/21/1997SE |
| K935633 | No-MesKNT · Traditional | 09/30/1994SE |
| K921946 | Tum-E-Vac Bite BlockJXL · Traditional | 12/09/1992SE |
| K885220 | Percutaneous Endoscopic Gastrostomy KitKNT · Traditional | 09/25/1989SEKD |
| K894927 | Surgi SqueezKZD · Traditional | 09/11/1989SE |
| K883977 | Surgi-Cuf Sterile/Non-Sterile DisposableDXQ · Traditional | 02/10/1989SE |
| K860599 | Ethox Lavage TubeKDH · Traditional | 03/11/1986SE |
| K841512 | Ethox Relia-Flo 2001 Enteral FeedFRN · Traditional | 05/21/1984SE |
Questions and answers
When was Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos. cleared by the FDA?
Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos. (K844988) received a 510(k) decision of Substantially Equivalent on April 4, 1985, 99 days after the submission was received.
What is the product code of K844988?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.