# K053550: Ambu Blue Sensor Neo and Neo X

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Oct 25, 2006 after 309 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ambu® Blue Sensor NF: named in the summary without a submission number
- (no number) Ambu® Blue Sensor BRS: named in the summary without a submission number

## Most influential descendants
- K100129: Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X (2010), 0 descendants of its own
- K080106: Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive (2008), 0 descendants of its own

## Indications for use
The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG 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/K053550
Methodology: https://510kreport.com/methodology