BP Pump
by Bio-Tek Instruments, Inc. 510(k)
Active
510(k) K921074
Overview
The BP Pump is a multi-purpose test instrument for Non-Invasive Blood Pressure Monitors (NIBPMs). It is used for simulation, artifact generation, and testing of blood pressure monitoring devices.
The device is supplied as a reusable test instrument and is intended for use in clinical or laboratory settings. It has received FDA 510(k) clearance under product code DXN and was found substantially equivalent to a predicate device. No claims are made regarding sterility, MRI safety, or specific sizes beyond what is documented in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921074 | Date9 Oct 1992 | 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- Withdrawn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
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bio-Tek Instruments, Inc.
Questions
What is the BP Pump used for?
The BP Pump is used for simulation, artifact generation, and testing of non-invasive blood pressure monitors (NIBPMs) to verify their accuracy and performance.
Is the BP Pump reusable or single-use?
The BP Pump is supplied as a reusable test instrument, designed for repeated use in clinical or laboratory environments.
Does the BP Pump require sterilization before use?
No claims are made regarding sterility for the BP Pump, so it is not supplied sterile and sterilization is not required or indicated by the manufacturer.
What regulatory pathway was used for the BP Pump?
The BP Pump received FDA 510(k) clearance under product code DXN, demonstrating substantial equivalence to a predicate device through a traditional review process.