# K901555: Model 1730 Neotrode with Attached Leadwire

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 18, 1990 after 106 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 23, 2010 · Not classified · Z-1493-2011: Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.

Source page: https://510kreport.com/device/K901555
Methodology: https://510kreport.com/methodology