FDA product code PTY: Computerized Cognitive Assessment Aid, Exempt
PTY is the FDA product code for computerized cognitive assessment aid, exempt. It is a Class II device, regulated under 21 CFR 882.1470 and reviewed by the Neurology panel. Devices under PTY 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 PKQ, 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 882.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Computerized Cognitive Assessment Aid, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 882.1470 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for PTY devices
openFDA lists no recalls for product code PTY.
Frequently asked questions
What is FDA product code PTY?
PTY is the FDA product code for computerized cognitive assessment aid, exempt. It is a Class II device, regulated under 21 CFR 882.1470 and reviewed by the Neurology panel.
What device class is PTY?
Class II, regulation 21 CFR 882.1470. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PTY
- Run a recall and safety report across every PTY manufacturer
- Watch product code PTY 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.