FDA product code KCD: Bougie, Esophageal, Ent
KCD is the FDA product code for bougie, esophageal, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under KCD, from 3 different applicants. The average 510(k) review took 26 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Bougie, Esophageal, Ent |
| 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 KCD clearance
Top KCD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Glaxo, Inc. | 1 | 1984-11-09 |
| Kelleher Corp. | 1 | 1982-08-25 |
| Pilling Co. | 1 | 1980-04-24 |
Most recent KCD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844169 | Glaxo, Inc. | VOLUMATIC | 1984-11-09 | 15 |
| K822258 | Kelleher Corp. | ESOPHAGEAL BOUGIES | 1982-08-25 | 27 |
| K800623 | Pilling Co. | JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE | 1980-04-24 | 36 |
Recalls for KCD devices
openFDA lists no recalls for product code KCD.
Frequently asked questions
What is FDA product code KCD?
KCD is the FDA product code for bougie, esophageal, ent. 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 KCD?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCD?
Across 3 cleared submissions the average was 26 days from receipt to decision (median 27).
Which companies have the most KCD clearances?
Glaxo, Inc. (1); Kelleher Corp. (1); Pilling Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KCD
- Run a recall and safety report across every KCD manufacturer
- Watch product code KCD 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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