# K240087: RT Carbon ECG Leads

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: Sep 13, 2024 after 246 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970755 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970755: Stealthshield, Vital Connections, Inc. (1997) Summary page 6.

## Indications for use
The Ivy Biomedical RT Carbon ECG Leads are intended for use in X-ray imaging environments. They connect between ECG electrodes that are placed on the patient by a trained healthcare professional and an ECG trunk cable that connects to the ECG monitoring device. The RT Carbon ECG Leads are reusable and nonsterile. The RT Carbon ECG Leads are intended for adult, pediatric and neonatal patient populations.

Source page: https://510kreport.com/device/K240087
Methodology: https://510kreport.com/methodology