FDA product code KCF: Dilator, Esophageal, Ent
KCF is the FDA product code for dilator, 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 KCF. The average 510(k) review took 42 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Dilator, 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 KCF clearance
Top KCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Medical Products, Inc. | 3 | 1996-07-25 |
Most recent KCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962688 | Boston Medical Products, Inc. | MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE | 1996-07-25 | 14 |
| K923355 | Boston Medical Products, Inc. | PHARYNGEAL SALIVARY BYPASS TUBE | 1992-10-06 | 90 |
| K812305 | Boston Medical Products, Inc. | MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE | 1981-09-08 | 22 |
Recalls for KCF devices
openFDA lists no recalls for product code KCF.
Frequently asked questions
What is FDA product code KCF?
KCF is the FDA product code for dilator, 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 KCF?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KCF?
Across 3 cleared submissions the average was 42 days from receipt to decision (median 22).
Which companies have the most KCF clearances?
Boston Medical Products, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code KCF
- Run a recall and safety report across every KCF manufacturer
- Watch product code KCF 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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