# K032537: Draeger MICRO2+ and Masimo Minisat

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Nov 25, 2003 after 99 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: 4 generations back to K946306 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030640: Siemens MICRO2+ with Vai Software, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K012770: Infinity MICRO2+, Siemens Medical Solutions USA, Inc. (2002)
- K013792: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2001)

## Indications for use
The MICR02+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.

Source page: https://510kreport.com/device/K032537
Methodology: https://510kreport.com/methodology