# K192471: RHIN1 Stylus

- Pathway: 510(k) (Traditional)
- Applicant: Aerin Medical, Inc.
- Decided: Dec 20, 2019 after 101 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: 4 generations back to K000778 (2000). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162810: InSeca ARC Stylus, Aerin Console, Aerin Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K212666: Neuromark System (2021), 3 descendants of its own
- K222032: NEUROMARK System (2022), 2 descendants of its own
- K250048: NEUROMARK System (NMK00301) (2025), 1 descendant of its own
- K261833: NEUROMARK System (NMK00301) (2026), 0 descendants of its own

## Indications for use
The RHIN1 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/K192471
Methodology: https://510kreport.com/methodology