Aneroid Sphygmomanometer with Stethoscope
by Shanghai Caremate Medical Device Co., Ltd. EUDAMED510(k)
Active
510(k) K211084
Overview
The Aneroid Sphygmomanometer with Stethoscope is a mechanical blood pressure measurement device designed to assess arterial blood pressure in adults and children. It operates by inflating a cuff around the upper arm to temporarily occlude the brachial artery, then gradually releasing pressure while monitoring via a stethoscope to determine systolic and diastolic readings.
This device is supplied as a reusable clinical instrument, intended for use in healthcare settings such as hospitals, clinics, and physician offices. It requires manual operation and is not MRI-safe; the cuff sizes (adult and pediatric) must be stored in a clean, dry environment to prevent contamination. Authorised under FDA 510K clearance (K211084) and compliant with MDD/MDR standards, it adheres to traditional review pathways for cardiovascular diagnostic devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK211084 | Date19 Oct 2021 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
- 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
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Questions
What types of patients can this aneroid sphygmomanometer be used to measure blood pressure for, and how does it differ from digital alternatives?
This device is specifically designed for measuring arterial blood pressure in both adults and children, making it suitable for a broad range of patients. Unlike digital alternatives, it relies on manual inflation and auscultation via a stethoscope to determine systolic and diastolic readings, which can be advantageous for users who prefer traditional methods or require precise manual adjustments. The mechanical nature also eliminates reliance on batteries or electronic components, which may be preferable in certain clinical settings.
Is this device single-use or reusable, and what storage conditions should be followed to maintain its integrity?
This aneroid sphygmomanometer is designed as a reusable clinical instrument, intended for use in healthcare settings like hospitals, clinics, and offices. To maintain its sterility and functionality, the cuffs (available in adult and pediatric sizes) must be stored in a clean, dry environment to prevent contamination. Proper cleaning and maintenance protocols should be followed after each use to ensure accurate and reliable measurements.
What regulatory pathways does this device follow, and how does that affect its use in different markets?
This device has undergone FDA 510(k) clearance (K211084) under the traditional review pathway for cardiovascular diagnostic devices, specifically within the Cardiovascular (CV) advisory committee. It is also compliant with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) standards, which are relevant for markets within the European Economic Area. These regulatory pathways ensure the device meets safety and performance requirements for use in healthcare settings globally.
Can this device be used in environments where MRI scans are performed, and why might that be important for clinicians?
No, this aneroid sphygmomanometer is not MRI-safe. This is important for clinicians because MRI environments have strong magnetic fields that can interfere with or damage non-MRI-safe devices, posing risks to both patients and equipment. Clinicians should ensure the device is not brought into MRI areas to avoid potential hazards or inaccuracies in measurements.