Jostra FlowProbe FP-32E
by Jostra AG 510(k)
Active
510(k) K013939
Overview
The Jostra FlowProbe FP-32E is an Extravascular Blood-Flow Probe, classified as a Class II medical device. It is designed to measure blood flow in extracorporeal circulation systems, providing real-time volumetric flow rate data during procedures lasting up to six hours. Constructed from polycarbonate, it is engineered for precision monitoring in cardiovascular applications requiring accurate hemodynamic assessment.
This device is supplied as a single-use, non-sterile probe in a 3/8" size, intended for use in controlled clinical environments such as operating rooms or cardiac catheterization labs. It is regulated under FDA 510(k) clearance (K013939) and falls under the Cardiovascular advisory committee classification. Storage and handling must comply with manufacturer guidelines to ensure proper functionality and safety before use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013939 | Date14 Dec 2001 | 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- Withdrawn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
- DPT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2120
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Jostra AG
Questions
What is the primary use of the Jostra FlowProbe FP-32E in clinical settings?
The Jostra FlowProbe FP-32E is designed to measure blood flow in extracorporeal circulation systems, providing real-time volumetric flow rate data during procedures. This makes it particularly useful in cardiovascular applications, such as surgeries or catheterization labs, where accurate hemodynamic assessment is critical for up to six hours of continuous use.
Is the Jostra FlowProbe FP-32E intended for single-use or reusable applications?
The Jostra FlowProbe FP-32E is explicitly labeled as a single-use device. This classification ensures patient safety and reliability, as it is not intended for reuse after a single procedure.
What size is the probe, and is it sterile when supplied?
The probe is supplied in a single size, 3/8", and is non-sterile. It is intended for use in controlled clinical environments like operating rooms or cardiac catheterization labs, where it can be sterilized prior to use if required by the facility’s protocols.
How is the regulatory status of this device determined, and what committee oversees its classification?
The Jostra FlowProbe FP-32E is classified as a Class II medical device and has received FDA 510(k) clearance under the traditional review pathway. Its classification falls under the Cardiovascular advisory committee (CV), which oversees submissions related to cardiovascular devices.
What materials is the probe constructed from, and how does this affect its durability?
The probe is constructed from polycarbonate, a material chosen for its precision and reliability in measuring blood flow. Polycarbonate is durable enough to withstand the demands of extracorporeal circulation systems while maintaining accuracy for up to six hours of continuous use.