# K222712: Fogg System Patient Monitoring Cables

- Pathway: 510(k) (Traditional)
- Applicant: Fogg System Company, Inc.
- Decided: Nov 22, 2023 after 440 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K941811 (1994). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203635: Patient Monitoring Cables, Jkh USA, LLC (2021) Summary page 4.

## Indications for use
The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.

Source page: https://510kreport.com/device/K222712
Methodology: https://510kreport.com/methodology