Digital Sphygmomanometer BP-2500
by Pollenex Associated Mills, Inc. 510(k)
Active
510(k) K843446
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843446 | Date15 May 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
A digital sphygmomanometer is a device used to measure blood pressure non-invasively. The Digital Sphygmomanometer BP-2500 is an electronic blood pressure monitor designed for automated systolic and diastolic pressure measurement.
It is supplied as a reusable device intended for use in clinical or home settings. The device received FDA 510(k) clearance (K843446) on May 15, 1985, and is classified under product code DXN with cardiovascular advisory committee review. No sterility, single-use, MRI safety, size, or storage specifications are provided in the data.
Other devices from Pollenex Associated Mills, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Digital Sphygmomanometer BP-2500 used for?
The Digital Sphygmomanometer BP-2500 is used to measure blood pressure non-invasively by providing automated systolic and diastolic pressure readings, making it suitable for routine monitoring in clinical or home environments.
Is the Digital Sphygmomanometer BP-2500 reusable or single-use?
The device is supplied as a reusable device, meaning it is designed for multiple uses over time rather than being discarded after a single application, which aligns with its intended use in ongoing blood pressure monitoring.
Where can the Digital Sphygmomanometer BP-2500 be used?
It is intended for use in both clinical and home settings, allowing flexibility for healthcare professionals and individuals to monitor blood pressure in various environments without requiring specialized infrastructure.
Does the Digital Sphygmomanometer BP-2500 require sterilization before use?
No sterility specifications are provided in the device data, and since it is a reusable non-invasive blood pressure monitor that contacts only intact skin, it does not require sterilization; routine cleaning between uses is sufficient per standard practice for such devices.
What regulatory pathway was used for the Digital Sphygmomanometer BP-2500?
The device received FDA 510(k) clearance under submission K843446 on May 15, 1985, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.