# K100129: Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X

- Pathway: 510(k) (Abbreviated)
- Applicant: Ambu A/S
- Decided: Jun 11, 2010 after 143 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- 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 K902407 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902407: NF-50-E Disposable Ecg Electrode, Medicotest, Inc. (1990) Summary page 1.
- K921579: BR-50-J Disposable Ecg Electrode, Medicotest, Inc. (1992) Summary page 1.
- K011564: Neolead, Neotech Products, Inc. (2002) Summary page 1.
- K053550: Ambu Blue Sensor Neo and Neo X, Ambu A/S (2006) Summary page 1.

## Indications for use
The Ambu® Blue Sensor PJEO and Ambu® Blue Sensor NEO X electrodes are made for EGG monitoring of neonatal and paediatric patients. The EGG electrodes are applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The electrodes are for single patient use only.

Source page: https://510kreport.com/device/K100129
Methodology: https://510kreport.com/methodology