FDA product code PKA: External Upper Esophageal Sphincter (Ues) Compression Device
PKA is the FDA product code for external upper esophageal sphincter (ues) compression device. It is a Class II device, regulated under 21 CFR 874.5900 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under PKA. The average 510(k) review took 108 days (median 108). 1 De Novo request was granted under it.
Definition
The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.
Classification
| Field | Value |
|---|---|
| Device name | External Upper Esophageal Sphincter (Ues) Compression Device |
| Device class | Class II |
| Regulation | 21 CFR 874.5900 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for PKA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 108 |
Compare with all 510(k) review times · Search every PKA clearance
Top PKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Somna Therapeutics, LLC | 1 | 2018-04-13 |
Most recent PKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173934 | Somna Therapeutics, LLC | Reza Band, Reflux Band | 2018-04-13 | 108 |
Recalls for PKA devices
openFDA lists no recalls for product code PKA.
Frequently asked questions
What is FDA product code PKA?
PKA is the FDA product code for external upper esophageal sphincter (ues) compression device. It is a Class II device, regulated under 21 CFR 874.5900 and reviewed by the Ear, Nose and Throat panel.
What device class is PKA?
Class II, regulation 21 CFR 874.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKA?
Across 1 cleared submissions the average was 108 days from receipt to decision (median 108).
Which companies have the most PKA clearances?
Somna Therapeutics, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PKA
- Run a recall and safety report across every PKA manufacturer
- Watch product code PKA 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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