# K222032: NEUROMARK System

- Pathway: 510(k) (Traditional)
- Applicant: Neurent Medical
- Decided: Oct 26, 2022 after 107 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: 6 generations back to K000778 (2000). 6 ancestors in all.
2 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)
- K212666: Neuromark System, Neurent Medical (2021) Summary page 4.

## Most influential descendants
- K250048: NEUROMARK System (NMK00301) (2025), 1 descendant of its own
- K261833: NEUROMARK System (NMK00301) (2026), 0 descendants of its own

## Indications for use
The NEUROMARK® 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/K222032
Methodology: https://510kreport.com/methodology