# K212666: Neuromark System

- Pathway: 510(k) (Traditional)
- Applicant: Neurent Medical
- Decided: Oct 22, 2021 after 60 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: 5 generations back to K000778 (2000). 5 ancestors in all.
3 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)
- K192471: RHIN1 Stylus, Aerin Medical, Inc. (2019) Summary page 4.

## Most influential descendants
- 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 NEUROMARKT™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

Source page: https://510kreport.com/device/K212666
Methodology: https://510kreport.com/methodology