Home Blood Pressure Kit, Aneroid
by Yamasu Co., Ltd. 510(k)
Active
510(k) K884420
Overview
This device is an Aneroid Home Blood Pressure Kit, designed for measuring systolic and diastolic blood pressure in a clinical or home setting. It employs an aneroid manometer to gauge arterial pressure via auscultation or palpation, typically paired with an inflatable cuff and stethoscope for accurate readings. The kit is intended for non-invasive monitoring of blood pressure in adults.
The Home Blood Pressure Kit, Aneroid is supplied as a reusable, non-sterile medical device and is regulated under FDA 510(k) clearance K884420 with a Substantially Equivalent (SESE) determination. It falls under product code DXY and regulation 870.3610, classified for cardiovascular use. No third-party review was involved, and the device is intended for use in environments where blood pressure monitoring is required, such as homes or clinics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884420 | Date25 Aug 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXY
- FDA applicant
- Yamasu Co. , Ltd.
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Yamasu Co., Ltd.
Questions
What is the primary purpose of the Home Blood Pressure Kit, Aneroid, and where can it be used?
The Home Blood Pressure Kit, Aneroid, is designed for measuring systolic and diastolic blood pressure in adults using an aneroid manometer, typically paired with an inflatable cuff and stethoscope. It is intended for non-invasive monitoring in both clinical and home settings, such as hospitals, clinics, or patient homes, where regular blood pressure checks are required.
Is this device reusable or single-use, and what does that mean for maintenance?
This device is explicitly labeled as reusable, meaning it is intended for repeated use after cleaning and disinfection. Since it is non-sterile, proper maintenance—such as cleaning between uses and following manufacturer guidelines—is essential to ensure accuracy and hygiene, particularly in shared clinical environments.
How is the Home Blood Pressure Kit, Aneroid regulated, and what does the FDA 510(k) clearance indicate?
The device holds an FDA 510(k) clearance (K884420) with a Substantially Equivalent (SESE) determination, meaning it has been deemed comparable to a legally marketed predicate device in terms of safety and effectiveness. This clearance falls under product code DXY and regulation 870.3610, classifying it for cardiovascular use. No third-party review was involved in this submission.
What components are included in the Home Blood Pressure Kit, Aneroid, and how does it function?
The kit includes an aneroid manometer (for pressure measurement), an inflatable cuff (to occlude the artery), and a stethoscope (for auscultation or palpation). It works by inflating the cuff to temporarily stop blood flow, then gradually releasing pressure while listening for sounds (Korotkoff sounds) to determine systolic and diastolic readings—a method known as auscultatory blood pressure measurement.
Are there specific storage requirements for this device, and why might they matter?
While the data does not specify exact storage conditions, reusable medical devices like this one should generally be stored in a clean, dry environment to prevent damage or contamination. Proper storage ensures the cuff’s elasticity and manometer’s accuracy remain intact over time, especially since it’s intended for long-term use in both clinical and home settings.