# K182868: INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Jan 8, 2019 after 88 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001842 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 4.

## Most influential descendants
- K211561: INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) (2021), 0 descendants of its own

## Recalls of this device
- Jan 9, 2024 · Class II · Z-1732-2024: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

## Indications for use
The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals greater than 40 kg at risk for reduced-flow or no-flow ischemic states. The INVOS™ Adult rSO2 Sensor is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing >40 kilograms. This sensor is only intended to be used with INVOS™ Near Infrared Spectroscopy (NIRS) technology including monitoring systems and devices integrated with INVOS™ NIRS technology. For additional information regarding setup and use of the INVOS™ System including indications for use, contraindications, warnings and cautions, consult the Monitoring System Operator's Manual.

Source page: https://510kreport.com/device/K182868
Methodology: https://510kreport.com/methodology