FDA product code PTO: Tester, Auditory Impedance, Exempt
PTO is the FDA product code for tester, auditory impedance, exempt. It is a Class II device, regulated under 21 CFR 874.1090 and reviewed by the Ear, Nose and Throat panel. Devices under PTO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is the class II exempt counterpart of ETY, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 874.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Tester, Auditory Impedance, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 874.1090 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for PTO devices
openFDA lists no recalls for product code PTO.
Frequently asked questions
What is FDA product code PTO?
PTO is the FDA product code for tester, auditory impedance, exempt. It is a Class II device, regulated under 21 CFR 874.1090 and reviewed by the Ear, Nose and Throat panel.
What device class is PTO?
Class II, regulation 21 CFR 874.1090. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PTO
- Run a recall and safety report across every PTO manufacturer
- Watch product code PTO 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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