# K250048: NEUROMARK System (NMK00301)

- Pathway: 510(k) (Traditional)
- Applicant: Neurent Medical, Ltd.
- Decided: May 29, 2025 after 139 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: 7 generations back to K000778 (2000). 7 ancestors in all.
1 later device descends 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)
- K222032: NEUROMARK System, Neurent Medical (2022) Summary page 5.

## Most influential descendants
- 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/K250048
Methodology: https://510kreport.com/methodology