# K900519: Classic Ecg/Stimulating NO. 1700 Series

- Pathway: 510(k) (Traditional)
- Applicant: Classic Medical Products, Inc.
- Decided: Mar 19, 1990 after 45 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.
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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130816: Interx Sterile Self-Adhesive Dual Electrode (Issde) (2013), 0 descendants of its own
- K954951: Taylor General Purpose Monitoring Electrode (1996), 0 descendants of its own

## Recalls of this device
- Feb 9, 2012 · Class II · Z-0499-2013: Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have bee

Source page: https://510kreport.com/device/K900519
Methodology: https://510kreport.com/methodology