# K221907: RhinAer® Stylus (FG1393)

- Pathway: 510(k) (Special)
- Applicant: Aerin Medical, Inc.
- Decided: Jul 29, 2022 after 29 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K260522: RhinAer+ Stylus (2026), 0 descendants of its own
- K260255: AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) (2026), 0 descendants of its own

## 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/K221907
Methodology: https://510kreport.com/methodology