# K082888: Infinity Nellcor Oximax Smartpod, Model MS23997

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Nov 26, 2008 after 57 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 K941811 (1994). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061329: Infinity Masimo Set SP02 Pod, Draeger Medical Systems, Inc. (2006) Summary page 1.

## Indications for use
The Infinity Nellcor OxiMax SmartPod is intended for use under the direct supervision of a licensed healthcare practitioner (i.e. Physicians, Nurses, and Technicians). It is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Infinity Nellcor OxiMax SmartPod is indicated for use with adult, pediatric, and neonatal patients. The Infinity Nellcor OxiMax SmartPod and accessories are indicated for use with patients who are well or poorly perfused in hospitals and hospital type facilities. The Infinity Nellcor OxiMax SmartPod is not compatible for use in home care environment and in hospitals where CT, Hyperbaric chambers and MRI equipment are in use.

Source page: https://510kreport.com/device/K082888
Methodology: https://510kreport.com/methodology