Aneroid and Mercurial Sphygmomanometers
FDA 510(k) K962655 · American Diagnostic Corp.
510(k) numberK962655
Submission
- Device name
- Aneroid and Mercurial Sphygmomanometers
- Applicant
- American Diagnostic Corp.
West Babylon, NY, US - Received
- July 8, 1996
- Decision date
- January 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K060321 | Adscope 657BK Electronic Stethoscope, Model 657BKDQD · Traditional | 05/15/2006SE |
| K012304 | Adc 656 Electronic StethoscopeDQD · Traditional | 11/01/2001SE |
| K940686 | Electronic ThermometersFLL · Traditional | 07/08/1994SE |
| K935944 | Proscopes and AdscopesLDE · Traditional | 03/03/1994SE |
| K932145 | Coagulation Reference Plasma, NormalGIZ · Traditional | 10/18/1993SE |
| K894169 | Biotel Microalbuminuria (TM)JIR · Traditional | 09/18/1989SE |
| K893608 | Actichrome Atiii KitJBQ · Traditional | 06/23/1989SE |
| K884941 | Acticlot C KitGGP · Traditional | 03/13/1989SE |
Questions and answers
When was Aneroid and Mercurial Sphygmomanometers cleared by the FDA?
Aneroid and Mercurial Sphygmomanometers (K962655) received a 510(k) decision of Substantially Equivalent on January 27, 1997, 203 days after the submission was received.
What is the product code of K962655?
The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.