Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173044 FDA 510(k)
- FDA Product Code
- DXQ 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, classified as a sphygmomanometer cuff under medical nomenclature. It measures arterial blood pressure by inflating a cuff around the upper arm or wrist to occlude the brachial artery, then gradually releasing pressure to determine systolic and diastolic readings. The cuffs are designed for use with automated or manual blood pressure monitors to assess cardiovascular health and diagnose hypertension or hypotension.
The cuffs are available in reusable and disposable variants, supplied sterile or non-sterile depending on the model. Both types are intended for single-patient use (disposable) or repeated use (reusable) in clinical, home, or ambulatory settings. The reusable version requires cleaning and disinfection between uses, while the disposable version is intended for one-time use. Both comply with FDA 510(k) clearance (K173044) and EU MDR regulations, ensuring safety and performance standards for blood pressure measurement.
Frequently asked questions
What are the key differences between the reusable and disposable blood pressure cuffs from Ningbo Albert Novosino?
The reusable cuff is designed for repeated use in clinical, home, or ambulatory settings after cleaning and disinfection between patients. In contrast, the disposable cuff is intended for single-patient use only, eliminating the need for reprocessing. Both types measure arterial blood pressure via the same method—occluding the brachial artery—but differ in their sterility (sterile or non-sterile options available) and lifecycle, with the reusable version requiring maintenance between uses.
How should I determine which size cuff to use for accurate blood pressure readings?
The device data does not specify exact sizing details, but standard blood pressure cuffs typically require matching the bladder width to the patient’s arm circumference (e.g., adult, pediatric, or thigh sizes). Since this product is classified as a sphygmomanometer cuff, you should refer to the manufacturer’s instructions or packaging for precise sizing guidance, as improper cuff fit can lead to inaccurate readings.
Are these cuffs compatible with both manual and automated blood pressure monitors?
Yes, the description confirms these cuffs are designed for use with *both* automated and manual blood pressure monitors. Compatibility is ensured by their standard sphygmomanometer cuff classification, which aligns with common measurement protocols for arterial blood pressure assessment.
What regulatory pathways have these cuffs undergone, and how does that affect their use?
The cuffs have undergone FDA 510(k) clearance (K173044) under the Traditional pathway, with a decision of Substantially Equivalent to a predicate device, and comply with EU MDR regulations. This means they meet U.S. and EU safety/performance standards for blood pressure measurement, but the specific regulatory status does not dictate clinical indications—only that they’re legally marketable in those regions for their intended purpose (measuring arterial blood pressure).
Can the reusable cuff be used in a hospital setting where multiple patients are treated?
Yes, the reusable cuff is explicitly designed for repeated use in clinical settings, provided it undergoes proper cleaning and disinfection between patients. This distinguishes it from the disposable version, which is intended for single-patient use only. Adherence to reprocessing protocols is critical to maintain sterility and prevent cross-contamination in shared environments like hospitals.
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: reusable - Wiktionary, the free dictionary
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173044 | Class II | Active |
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Manufacturer
- Manufacturer
- Ningbo Albert Novosino Co., Ltd.
Sources (2)
- FDA 510(k) K173044 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026