# K201179: GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jul 20, 2020 after 80 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 53 ancestors in all.
No later device cites it as a predicate yet.
1 of 54 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172482: The Nellcor pulse oximetry monitor interface cable, Covidien (2017) Summary page 5.

## Indications for use
The GE ApexPro CH SpO2 – Nellcor Cable is indicated for prescription use only for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonate, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities. • Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general care floor (GCF). • Note: Hospital-type facilities include step-down units and long-term care facilities. The GE ApexPro FH SpO2 – Nellcor Cable is indicated for prescription use only for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities. • Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general care floor (GCF). • Note: Hospital-type facilities include step-down units and long-term care facilities.

Source page: https://510kreport.com/device/K201179
Methodology: https://510kreport.com/methodology