# K260929: Neonav ECG Tip Location System

- Pathway: 510(k) (Special)
- Applicant: Navi Medical Technologies
- Decided: Apr 17, 2026 after 28 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: 13 generations back to K001901 (2000). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241910: Neonav ECG Tip Location System, Navi Medical Technologies (2025) Summary page 5.

## Indications for use
Neonav is indicated for navigation and positioning of central venous access devices (CVADs) of at least 1 Fr 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), Neonav can be used with PICCs and CICCs; and in neonates (from birth to 1 month of age), Neonav can be used with PICCs, CICCs, and umbilical venous catheters (UVCs). 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/K260929
Methodology: https://510kreport.com/methodology