Reusable Blood Pressure Cuff
by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. 2 variants
510(k) K171889
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171889 | Date19 Dec 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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
Overview
AI-generated summary, 1 Oct 2026
This device is a Reusable Blood Pressure Cuff, classified under the FDA’s DXQ product code as a cardiovascular measurement instrument. It is designed to measure arterial blood pressure in adults and children by inflating around the upper arm or wrist to occlude the brachial or radial artery, enabling systolic and diastolic pressure readings via a connected sphygmomanometer. Constructed for repeated clinical use, it adheres to traditional 510(k) clearance standards for non-invasive blood pressure monitoring devices.
The cuff is intended for reusable clinical or home use in settings such as hospitals, outpatient clinics, or patient self-monitoring. Supplied sterile upon first use, it requires cleaning and disinfection between patients to maintain hygiene. Compatible with standard sphygmomanometers, it is not MRI-safe and must be stored in a clean, dry environment to preserve its integrity. Authorized under FDA 510(k) clearance (K171889) as substantially equivalent to predicate devices, it complies with cardiovascular measurement regulations without additional third-party certification.
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Questions
AI-generated answers, 1 Oct 2026
What is the reusable blood pressure cuff designed for?
This cuff is specifically designed to measure arterial blood pressure in both adults and children. It works by inflating around the upper arm or wrist to occlude the brachial or radial artery, allowing for accurate systolic and diastolic pressure readings when connected to a compatible sphygmomanometer. Its reusable design makes it suitable for clinical settings like hospitals or outpatient clinics, as well as for patient self-monitoring at home.
How is the cuff supplied and what are its initial hygiene requirements?
The cuff is supplied sterile upon first use to ensure cleanliness before initial clinical or home use. After the first use, it requires thorough cleaning and disinfection between patients to maintain hygiene standards, as it is intended for repeated clinical or home use. This ensures safe and reliable measurements across multiple users.
Is this cuff compatible with all types of sphygmomanometers?
The cuff is designed to be compatible with standard sphygmomanometers, meaning it should work with most commonly used devices for blood pressure measurement. However, compatibility may depend on the specific brand or model of the sphygmomanometer, so it’s best to verify with the manufacturer if there are any known restrictions or requirements.
What storage conditions are required to maintain the cuff’s integrity?
To preserve its functionality and ensure accurate measurements, the cuff must be stored in a clean, dry environment. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions can compromise the material or affect its performance over time.
Can this cuff be used in an MRI environment?
No, this cuff is not MRI-safe. If used in or near an MRI machine, it could pose a risk to both the patient and the imaging equipment due to potential interference or damage from the magnetic fields. Always check the manufacturer’s guidelines or consult with medical staff before using it in proximity to MRI machines.