# K973663: Paljet-B

- Pathway: 510(k) (Traditional)
- Applicant: Golden Gate Bio-Device
- Decided: Feb 10, 1998 after 138 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.
23 later devices descend from it; 1 cites it directly.
0 of 24 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) WaveTracer: named in the summary without a submission number

## Most influential descendants
- K982470: Ecg Electrodes Apron (1998), 22 descendants of its own
- K043361: Accuheart Electrode Belt (2005), 21 descendants of its own
- K063044: Cardiobelt Electrode Belt (2007), 18 descendants of its own
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own

## Indications for use
The Paljet-B patient cable system is a reusable ECG suction electrode system. It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market.

Source page: https://510kreport.com/device/K973663
Methodology: https://510kreport.com/methodology