Blood Pressure Recorder
510(k) K781932
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781932 | Date29 Nov 1978 | 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- Withdrawn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
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Blood Pressure Recorder is a noninvasive device classified under product code DXN, designed to measure and record blood pressure parameters. It provides signals from which systolic, diastolic, and mean arterial pressures can be derived using transducers applied to the body surface. This device facilitates continuous or intermittent monitoring of blood pressure in clinical or ambulatory settings. Its primary function is to assist in assessing cardiovascular health and diagnosing hypertension or other related conditions.
The Blood Pressure Recorder is supplied as a reusable medical device and is intended for use in clinical environments. It requires calibration and maintenance to ensure accurate readings. The device was granted FDA 510(k) clearance under K781932, with a decision date of November 29, 1978, and is regulated under the Cardiovascular advisory committee. No specific sterility or single-use designation is indicated in the available data.
Other devices from Cardiodyne, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Cardiodyne Blood Pressure Recorder?
The Blood Pressure Recorder is designed to measure and record blood pressure parameters noninvasively, enabling clinicians to derive systolic, diastolic, and mean arterial pressure readings. It supports continuous or intermittent monitoring in clinical or ambulatory settings, helping assess cardiovascular health and diagnose conditions like hypertension. The device uses transducers applied to the body surface to capture these signals.
Is the Cardiodyne Blood Pressure Recorder single-use or reusable?
The Blood Pressure Recorder is supplied as a reusable medical device. Unlike single-use devices, it requires regular calibration and maintenance to ensure accurate and reliable blood pressure readings over time. This design makes it suitable for long-term use in clinical environments where repeated monitoring is necessary.
Does the Blood Pressure Recorder come with any sterility guarantees?
The available data does not specify a sterility designation for the Blood Pressure Recorder. Since it is a reusable device, proper cleaning and maintenance protocols must be followed to prevent contamination and ensure patient safety. Clinicians should refer to the manufacturer’s instructions for cleaning and sterilization procedures.
What regulatory approval does the Cardiodyne Blood Pressure Recorder hold?
The Blood Pressure Recorder received FDA 510(k) clearance under the reference number K781932, with a decision date of November 29, 1978. It was classified as substantially equivalent to a predicate device and reviewed by the Cardiovascular Advisory Committee. This clearance allows it to be marketed in the U.S. for its intended use in measuring and recording blood pressure.
How does the Blood Pressure Recorder differ from traditional blood pressure cuffs?
Unlike traditional manual or digital blood pressure cuffs, which typically provide single or intermittent readings, the Blood Pressure Recorder is designed for continuous or intermittent monitoring of blood pressure parameters. It captures systolic, diastolic, and mean arterial pressure signals through transducers, making it ideal for tracking cardiovascular trends over time in clinical or research settings. This feature enhances diagnostic accuracy for conditions like hypertension.