FDA product code KZA: Device, Vein Location, Liquid Crystal
KZA is the FDA product code for device, vein location, liquid crystal. It is a Class I device, regulated under 21 CFR 880.6970 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under KZA, from 5 different applicants. The average 510(k) review took 133 days (median 106). FDA has posted 2 recalls for KZA devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Vein Location, Liquid Crystal |
| Device class | Class I |
| Regulation | 21 CFR 880.6970 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZA clearance
Top KZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harco Products | 2 | 1978-08-10 |
| Novarix Limited | 1 | 2016-02-24 |
| Vuetek Scientific, LLC | 1 | 2011-02-18 |
| Infrared Imaging Systems, Inc. | 1 | 2004-12-10 |
| Ironmaster, Inc. | 1 | 1998-12-14 |
Most recent KZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152088 | Novarix Limited | IV-eye | 2016-02-24 | 212 |
| K101838 | Vuetek Scientific, LLC | VTS1000 | 2011-02-18 | 232 |
| K042679 | Infrared Imaging Systems, Inc. | IR VIEWER | 2004-12-10 | 72 |
| K982612 | Ironmaster, Inc. | ESP7 VENOUS IMAGE | 1998-12-14 | 140 |
| K780884 | Harco Products | HYPO-GRIP | 1978-08-10 | 72 |
Recalls for KZA devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-03-14.
Frequently asked questions
What is FDA product code KZA?
KZA is the FDA product code for device, vein location, liquid crystal. It is a Class I device, regulated under 21 CFR 880.6970 and reviewed by the General Hospital panel.
What device class is KZA?
Class I, regulation 21 CFR 880.6970. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZA?
Across 6 cleared submissions the average was 133 days from receipt to decision (median 106).
Which companies have the most KZA clearances?
Harco Products (2); Novarix Limited (1); Vuetek Scientific, LLC (1); Infrared Imaging Systems, Inc. (1); Ironmaster, Inc. (1).
Have KZA devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2012-03-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KZA
- Run a recall and safety report across every KZA manufacturer
- Watch product code KZA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times