FDA product code KTA: Medium, Contrast, Radiologic
KTA is the FDA product code for medium, contrast, radiologic. It is a Unclassified device, reviewed by the Radiology panel. FDA has cleared 8 510(k) submissions under KTA, from 3 different applicants. The average 510(k) review took 55 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Medium, Contrast, Radiologic |
| Device class | Unclassified |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KTA clearance
Top KTA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medefield Pty. , Ltd. | 6 | 1980-06-17 |
| Central Pharmaceuticals, Inc. | 1 | 1980-05-30 |
| C.R. Bard, Inc. | 1 | 1976-11-09 |
Most recent KTA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K800840 | Medefield Pty. , Ltd. | MEDEFOAM-2 | 1980-06-17 | 63 |
| K800843 | Medefield Pty. , Ltd. | MEDEFIZZ A & MEDEFIZZ B | 1980-06-17 | 63 |
| K800841 | Medefield Pty. , Ltd. | MEDEBAR M | 1980-05-30 | 45 |
| K800839 | Medefield Pty. , Ltd. | MEDESCAN | 1980-05-30 | 45 |
| K800844 | Medefield Pty. , Ltd. | MEDEBAR XL | 1980-05-30 | 45 |
Recalls for KTA devices
openFDA lists no recalls for product code KTA.
Frequently asked questions
What is FDA product code KTA?
KTA is the FDA product code for medium, contrast, radiologic. It is a Unclassified device, reviewed by the Radiology panel.
What device class is KTA?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTA?
Across 8 cleared submissions the average was 55 days from receipt to decision (median 45).
Which companies have the most KTA clearances?
Medefield Pty. , Ltd. (6); Central Pharmaceuticals, Inc. (1); C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTA
- Run a recall and safety report across every KTA manufacturer
- Watch product code KTA 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.
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