FDA product code KCA: Tonsillectome
KCA is the FDA product code for tonsillectome. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KCA. The average 510(k) review took 33 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Tonsillectome |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KCA clearance
Top KCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-25 |
Most recent KCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822186 | Kelleher Corp. | MACKENZIE'S TONSILLECTOME | 1982-08-25 | 33 |
Recalls for KCA devices
openFDA lists no recalls for product code KCA.
Frequently asked questions
What is FDA product code KCA?
KCA is the FDA product code for tonsillectome. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KCA?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCA?
Across 1 cleared submissions the average was 33 days from receipt to decision (median 33).
Which companies have the most KCA clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KCA
- Run a recall and safety report across every KCA manufacturer
- Watch product code KCA 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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