# K061329: Infinity Masimo Set SP02 Pod

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Jul 7, 2006 after 56 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: 13 generations back to K941811 (1994). 58 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040259: Masimo Set Intellivue Pulse Oximeter Module, Masimo Corp. (2004) Summary page 1.
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 1.

## Most influential descendants
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set (2012), 23 descendants of its own
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (2018), 19 descendants of its own
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (2019), 18 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own

## Indications for use
The Infinity Masimo SET® Pod is intended for use under the direct supervision of a licensed healthcare practioner (i.e.. Physicians, Nurses, and Technicians). It is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Infinity Masimo SET® SpO2 Pod is indicated for use with adult, pediatric and neonatal patients. The Infinity Masimo SET' SpO 2 Pod and accessories are indicated for use during both motion and non-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital type facilities. MRI Compatibility Statement: The Infinity Masimo SET® SpO2 Pod is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K061329
Methodology: https://510kreport.com/methodology