# K954772: Quickels QS 200 System

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Jul 11, 1996 after 272 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 K864260 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864260: Applicard System (Ecg Electrode System), Grandcor Medical Systems (1987) Summary page 1.
- (no number) Welsh cup electrode: named in the summary without a submission number

## Indications for use
The Quickels QS 200 device is intended for use as a device to provide a firm and reliable attachment of an AgCl skin surface electrode to a patient or subject being measured during standard electrocardiography workups. The electrodes can be reused.

Source page: https://510kreport.com/device/K954772
Methodology: https://510kreport.com/methodology