Identifiers
- 510(k) Number
- K232772 FDA 510(k)
- FDA Product Code
- DXQ FDA 510(k)
- Models / Variants
- 1201D1 FDA 510(k)12L2D1 FDA 510(k)1202D1 FDA 510(k)12L3D1 FDA 510(k)1203D1 FDA 510(k)1204D1 FDA 510(k)1205D1 FDA 510(k)1206D1 FDA 510(k)1207D1-1# FDA 510(k)1207D1-2# FDA 510(k)1207D1-3# FDA 510(k)1207D1-4# FDA 510(k)1207D1-5# FDA 510(k)1201B1 FDA 510(k)12L2B1 FDA 510(k)1202B1 FDA 510(k)12L3B1 FDA 510(k)1203B1 FDA 510(k)1204B1 FDA 510(k)1205B1 FDA 510(k)1206B1 FDA 510(k)1207B1-1# FDA 510(k)1207B1-2# FDA 510(k)1207B1-3# FDA 510(k)1207B1-4# FDA 510(k)1207B1-5# FDA 510(k)1201W2 FDA 510(k)12L2W2 FDA 510(k)1202W2 FDA 510(k)12L3W2 FDA 510(k)1203W2 FDA 510(k)1204W2 FDA 510(k)1205W2 FDA 510(k)1206W2 and 1207W2 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1120 FDA 510(k)
- Regulation Number
- 870.1120 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a blood pressure cuff, designed to measure systolic and diastolic blood pressure and pulse rate. It is classified under the category of sphygmomanometers and is intended for clinical and home use to monitor arterial blood pressure in adults and pediatric patients, depending on the cuff size.
The cuffs are supplied in various sizes (D, B, W) and models (1201, 12L2, 1202, 12L3, 1203, 1204, 1205, 1206, 1207) to accommodate different arm circumferences. They are intended for single-use or reusable applications, depending on the model, and have received FDA 510(k) clearance under the traditional pathway as substantially equivalent to predicate devices. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What sizes and models of blood pressure cuffs are available for pediatric and adult patients, and how do I choose the right one?
The blood pressure cuffs come in three size categories—D, B, and W—each designed for different arm circumferences. The 'D' sizes are typically for adults with larger arms, 'B' for average-sized adults, and 'W' for pediatric or smaller adult arms. The models (e.g., 1201, 12L2, 1207) further refine the fit, so selecting the correct size depends on the patient’s arm circumference. For example, a pediatric patient would require a smaller cuff (e.g., 1207W2), while an adult with a larger arm might need a 'D' or 'B' variant. Always match the cuff size to the arm circumference for accurate readings.
Are these blood pressure cuffs intended for single-use or reusable applications, and how should I determine which type to purchase?
The blood pressure cuffs listed include models marked with a '#' symbol (e.g., 1207D1-1#) which are intended for single-use, while those without the symbol (e.g., 1201D1) are designed for reusable applications. The distinction is based on the model designation, so check the product code when ordering. Single-use cuffs are ideal for clinical settings where hygiene is critical, while reusable cuffs are better suited for home use or environments where sterilization is feasible.
How do I know if these cuffs are compatible with my existing blood pressure monitoring equipment?
The cuffs are designed to be compatible with standard sphygmomanometers, whether manual or electronic, as they follow the same technical standards for blood pressure measurement. However, compatibility depends on the specific device brand and model you’re using. Always verify with your equipment manufacturer or consult the cuff’s user manual to ensure proper fit and functionality. The FDA clearance under product code DXQ confirms they meet regulatory standards for blood pressure measurement, but actual compatibility should be confirmed with your device.
What storage requirements should I follow for these blood pressure cuffs, particularly if they are reusable?
The data does not specify sterility or detailed storage instructions, but reusable cuffs should be stored in a clean, dry environment to prevent contamination or damage. If used in clinical settings, follow standard infection control protocols, such as cleaning and disinfecting between uses. For single-use cuffs, adhere to manufacturer guidelines for handling and disposal. Always store cuffs away from direct sunlight or extreme temperatures to maintain their integrity.
What regulatory pathway was used for FDA clearance, and does this affect how I should use or procure these cuffs?
These blood pressure cuffs received FDA clearance through the traditional 510(k) pathway, specifically under the Cardiovascular (CV) advisory committee, and were deemed substantially equivalent (SESE) to predicate devices. This means the design and performance meet established safety and effectiveness standards for blood pressure measurement. The clearance does not alter clinical use—you should still follow medical guidelines for proper application and interpretation of readings—but it confirms the cuffs are legally marketable in the U.S. under this regulatory route.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shenzhen Plinma Technology Co. , Ltd. FDA 510(k) Products 2023, Shenzhen Plinma Technology Co. , Ltd. · DeviceClearance, K232772 · Blood Pressure Cuff… · DeviceClearance, Shenzhen Plinma Technology Co. , Ltd. - FDA Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232772 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Plinma Technology Co., Ltd
- FDA Applicant
- Shenzhen Plinma Technology Co. , Ltd.
Sources (1)
- FDA 510(k) K232772 24 fields · synced Oct 6, 2026