# K241910: Neonav ECG Tip Location System

- Pathway: 510(k) (Traditional)
- Applicant: Navi Medical Technologies
- Decided: Jan 19, 2025 after 202 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001901 (2000). 35 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141634: Nautilus Delta, Romedex International Srl (2015) Summary page 5.

## Most influential descendants
- K260929: Neonav ECG Tip Location System (2026), 0 descendants of its own
- K252792: PM2™ System with ECGuide™ Connector (2025), 0 descendants of its own

## Indications for use
Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1Fr in size. Neonav provides real-time catheter tip location information by using the patient’s cardiac electrical activity. Neonav is indicated for use as an alternative method to chest X-ray and fluoroscopy for all central venous access device tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Neonav can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Neonav can be used with PICCs and with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Neonav can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use. Limiting but not contraindicated situations for use of the Neonav are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous access device insertion, the use of an additional method is required to confirm catheter tip location.

Source page: https://510kreport.com/device/K241910
Methodology: https://510kreport.com/methodology