FDA product code PNZ: Eustachian Tube Balloon Dilation Device
PNZ is the FDA product code for eustachian tube balloon dilation device. It is a Class II device, regulated under 21 CFR 874.4180 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 8 510(k) submissions under PNZ, 5 in the last five years, from 5 different applicants. The average 510(k) review took 165 days (median 142); 93 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Classification
| Field | Value |
|---|---|
| Device name | Eustachian Tube Balloon Dilation Device |
| Device class | Class II |
| Regulation | 21 CFR 874.4180 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for PNZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 111 |
| 2018 | 1 | 216 |
| 2021 | 1 | 147 |
| 2022 | 1 | 97 |
| 2023 | 3 | 220 |
| 2026 | 1 | 93 |
Compare with all 510(k) review times · Search every PNZ clearance
Top PNZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acclarent, Inc. | 3 | 2026-02-19 |
| Entellus Medical, Inc. | 2 | 2022-04-12 |
| Spiggle & Theis Medizintechnik GmbH | 1 | 2023-08-03 |
| Fiagon GmbH | 1 | 2023-05-26 |
| Medtronic Xomed, Inc. | 1 | 2021-08-16 |
Most recent PNZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253612 | Acclarent, Inc. | Acclarent AERA Eustachian Tube Balloon Dilation System | 2026-02-19 | 93 |
| K230742 | Acclarent, Inc. | ACCLARENT AERA Eustachian Tube Dilation System | 2023-12-13 | 271 |
| K223542 | Spiggle & Theis Medizintechnik GmbH | TubaVent Balloon Dilatation System | 2023-08-03 | 251 |
| K230065 | Fiagon GmbH | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System | 2023-05-26 | 137 |
| K220027 | Entellus Medical, Inc. | Audion ET dilation system | 2022-04-12 | 97 |
Recalls for PNZ devices
openFDA lists no recalls for product code PNZ.
Frequently asked questions
What is FDA product code PNZ?
PNZ is the FDA product code for eustachian tube balloon dilation device. It is a Class II device, regulated under 21 CFR 874.4180 and reviewed by the Ear, Nose and Throat panel.
What device class is PNZ?
Class II, regulation 21 CFR 874.4180. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNZ?
Across 8 cleared submissions the average was 165 days from receipt to decision (median 142).
Which companies have the most PNZ clearances?
Acclarent, Inc. (3); Entellus Medical, Inc. (2); Spiggle & Theis Medizintechnik GmbH (1); Fiagon GmbH (1); Medtronic Xomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PNZ
- Run a recall and safety report across every PNZ manufacturer
- Watch product code PNZ 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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