FDA product code KDA: Prosthesis, Ptfe/Carbon-Fiber
KDA is the FDA product code for prosthesis, ptfe/carbon-fiber. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under KDA. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Ptfe/Carbon-Fiber |
| Device class | Class II |
| Regulation | 21 CFR 878.3500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KDA clearance
Top KDA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medcomp Technologies, Inc. | 1 | 1986-05-23 |
Most recent KDA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K861806 | Medcomp Technologies, Inc. | MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT) | 1986-05-23 | 14 |
Recalls for KDA devices
openFDA lists no recalls for product code KDA.
Frequently asked questions
What is FDA product code KDA?
KDA is the FDA product code for prosthesis, ptfe/carbon-fiber. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel.
What device class is KDA?
Class II, regulation 21 CFR 878.3500. Typical premarket route: 510(k).
How long does a 510(k) take for product code KDA?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most KDA clearances?
Medcomp Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KDA
- Run a recall and safety report across every KDA manufacturer
- Watch product code KDA 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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