Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat
FDA 510(k) K884421 · Pymah Corp.
510(k) numberK884421
Submission
- Device name
- Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat
- Applicant
- Pymah Corp.
Somerville, NJ, US - Received
- October 20, 1988
- Decision date
- January 13, 1989
- 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 |
|---|---|---|
| K952995 | Ati Ethylene Oxide Sterilization IndicatorJOJ · Traditional | 02/22/1996SE |
| K952408 | Ati Disposable Test Pack for Steam SterilizationJOJ · Traditional | 07/06/1995SE |
| K951063 | Ati Disposable Test Pack for Eo Gas SterilizationJOJ · Traditional | 05/10/1995SE |
| K934874 | Sterigage Eo 100%JOJ · Traditional | 04/18/1995SE |
| K943081 | Trimline 2000DXN · Traditional | 01/27/1995SE |
| K925745 | Ati(R) Disp Biological-Plus Test PackFRC · Traditional | 02/01/1994SE |
| K925496 | Ati Disposable Biological-Plus Test PackFRC · Traditional | 02/01/1994SE |
| K934180 | Slimline 3000DXQ · Traditional | 11/24/1993SE |
| K924681 | Glutaraldehyde MonitorsJOJ · Traditional | 11/17/1993SE |
| K925744 | Tempa-Kuff Single Pat Pre-Gaged Balanced Disp CuffDXQ · Traditional | 07/30/1993SE |
Questions and answers
When was Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat cleared by the FDA?
Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat (K884421) received a 510(k) decision of Substantially Equivalent on January 13, 1989, 85 days after the submission was received.
What is the product code of K884421?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.