VASCULAB #VSC21
by Medasonics, Inc. 510(k)
Active
510(k) K812609
Overview
The VASCULAB #VSC21 is a photoelectric, pneumatic or hydraulic plethysmograph, a device used to measure changes in blood volume within a limb or organ. It operates by detecting variations in light transmission or pressure changes to assess vascular function, typically in cardiovascular assessments.
This device is supplied as a reusable medical instrument and is classified as a Class 2 Cardiovascular device under FDA regulations (product code JOM). It was cleared through the Traditional 510(k) pathway in 1981, with a review period of 17 days, and is intended for use in clinical settings where vascular studies are conducted. No MRI safety or sterility specifications are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812609 | Date2 Oct 1981 | 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- Withdrawn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
- JOM
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2780
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Medasonics, Inc.
Questions
What types of vascular assessments can the VASCULAB #VSC21 perform, and how does it work?
The VASCULAB #VSC21 is a photoelectric, pneumatic, or hydraulic plethysmograph designed to measure changes in blood volume within a limb or organ. It detects variations in light transmission or pressure changes to evaluate vascular function, making it useful for assessing cardiovascular health in clinical settings. This helps clinicians study blood flow dynamics and diagnose conditions related to circulation.
Is the VASCULAB #VSC21 intended for single-use or repeated use in clinical settings?
The VASCULAB #VSC21 is supplied as a reusable medical instrument, meaning it is designed for multiple uses in clinical environments. Since it is not marked as sterile in the regulatory data, proper cleaning and maintenance protocols must be followed between uses to ensure accuracy and safety.
What regulatory pathway was used for FDA clearance of the VASCULAB #VSC21, and what does that mean for its use?
The VASCULAB #VSC21 was cleared through the Traditional 510(k) pathway in 1981, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms its compliance with FDA standards for Class 2 Cardiovascular devices (product code JOM), allowing its use in clinical settings for vascular studies as originally intended.
Are there multiple models or sizes available for the VASCULAB #VSC21, and how would I identify them?
The VASCULAB #VSC21 appears to have multiple FEI numbers listed in regulatory records, which may correspond to different models or configurations. These identifiers (e.g., 3009690509, 3008717264) are used for tracking and registration but do not directly indicate clinical specifications. For precise sizing or model details, consult the manufacturer’s documentation or contact Medasonics, Inc.
Does the VASCULAB #VSC21 have any special storage requirements, and can it be used in environments with MRI equipment?
The regulatory data does not specify sterility or MRI safety requirements for the VASCULAB #VSC21. Since it is reusable, proper storage (e.g., clean, dry, protected from physical damage) is recommended. However, its pneumatic/hydraulic components may pose risks in MRI environments, so it should not be used near MRI machines unless explicitly tested and certified for such use by the manufacturer.