Phlebotest 2000
510(k) K022047
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022047 | Date4 Nov 2002 | 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- Withdrawn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
- JOM
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2780
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Phlebotest 2000 is a photoelectric, pneumatic or hydraulic plethysmograph. It measures blood flow and venous filling in the extremities, aiding in the assessment of venous insufficiency and circulatory function. Designed as a diagnostic tool, it provides quantitative data on venous return and vascular health, supporting clinical evaluations in cardiovascular diagnostics.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings, such as hospitals or physician offices. It operates under sterile conditions when in direct contact with the patient, adhering to standard infection control protocols. The Phlebotest 2000 is classified under FDA regulation 870.2780 and holds a 510(k) clearance (K022047) for substantial equivalence to a previously cleared device. It is not MRI-safe and requires proper calibration and maintenance as specified by the manufacturer.
Other devices from Osborn Medical Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Phlebotest 2000 used for in clinical settings?
The Phlebotest 2000 is a diagnostic tool designed to measure blood flow and venous filling in extremities. It provides quantitative data on venous return and vascular health, aiding clinicians in assessing venous insufficiency and circulatory function. This helps support evaluations in cardiovascular diagnostics, particularly for patients with suspected vascular issues.
Is the Phlebotest 2000 a single-use or reusable device?
The Phlebotest 2000 is supplied as a reusable medical instrument. While it is intended for repeated use in clinical settings like hospitals or physician offices, it must be handled under sterile conditions whenever it comes into direct contact with patients. Proper cleaning and maintenance are essential to ensure sterility and functionality.
How is sterility maintained when using the Phlebotest 2000?
The Phlebotest 2000 adheres to standard infection control protocols when used in direct contact with patients. Since it is reusable, it must be thoroughly cleaned and sterilized between uses to prevent cross-contamination. Manufacturers typically provide guidelines for sterilization methods, such as autoclaving or chemical disinfection, to ensure safe and hygienic operation.
Does the Phlebotest 2000 require any special maintenance or calibration?
Yes, the Phlebotest 2000 requires proper calibration and maintenance as specified by Osborn Medical Corp. to ensure accurate measurements of blood flow and venous filling. Regular calibration helps maintain the device’s precision, while routine maintenance—such as checking for wear, leaks, or mechanical issues—ensures reliable performance over time. Following the manufacturer’s instructions is critical for optimal functionality.
Is the Phlebotest 2000 safe for use in an MRI environment?
No, the Phlebotest 2000 is not MRI-safe. If used in a facility with MRI capabilities, it must be kept away from the MRI scanner to avoid potential interference or damage to either the device or the imaging system. Always verify compatibility with local MRI protocols before use in mixed environments.