# K260522: RhinAer+ Stylus

- Pathway: 510(k) (Traditional)
- Applicant: Aerin Medical, Inc.
- Decided: May 18, 2026 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K221907 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221907: RhinAer® Stylus (FG1393), Aerin Medical, Inc. (2022) Summary page 5.

## Indications for use
The RhinAer+ Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

Source page: https://510kreport.com/device/K260522
Methodology: https://510kreport.com/methodology