Device, Vein Location, Liquid Crystal
The Liquid Crystal Vein Location Device is a non-invasive device that uses liquid crystal thermography to visualize superficial veins by detecting skin temperature differences caused by underlying blood flow, aiding clinicians in locating veins for venipuncture or IV placement. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KZA, regulated under 21 CFR 880.6970, in the General Hospital medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- KZA
- Device Class
- FDA class 1
- Regulation Number
- 880.6970
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K152088 | IV-eye | Feb 24, 2016 | Substantially Equivalent | Novarix Limited |
| K101838 | VTS1000 | Feb 18, 2011 | Substantially Equivalent | Vuetek Scientific, LLC |
| K042679 | IR VIEWER | Dec 10, 2004 | Substantially Equivalent | Infrared Imaging Systems, Inc. |
| K982612 | ESP7 VENOUS IMAGE | Dec 14, 1998 | Substantially Equivalent | Ironmaster, Inc. |
| K780884 | HYPO-GRIP | Aug 10, 1978 | Substantially Equivalent | Harco Products |
| K780883 | E-Z-JECTOR | Aug 10, 1978 | Substantially Equivalent | Harco Products |
FEI Numbers
This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.