# K211561: INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Dec 5, 2021 after 199 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: 5 generations back to K001842 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K182868: INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor, Covidien, LLC (2019) Summary page 4.
- K091224: Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-S, Somanetics Corp. (2009) Summary page 5.

## Recalls of this device
- Jan 9, 2024 · Class II · Z-1731-2024: 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 > 2.5 kg at risk for reduced-flow or no-flow ischemic states. For patients ≤ 2.5kg, the INVOS™ Patient Monitor, model PM7100 is only intended for adjunct trend monitoring of regional hemoglobin oxygen saturation of blood tissue beneath the sensor. It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood tissue beneath the sensor in any individual. The INVOS™ Pediatric rSO2 sensor is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing greater than 4 kg and less than 40 kilograms. This sensor is only intended to be used with INVOS™ PM7100 system with INVOS™ Near Infrared Spectroscopy (NIRS) technology. For additional information regarding setup and use of the INVOS™ PM7100 System including indications for use, contraindications, warnings and cautions, consult the Monitoring System Operator’s Manual. The INVOS™ OxyAlert NIRSensor disposable sensor Model IS is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing > 2.5 kilograms and < 40 kilograms or for trend monitoring of rSO2 of blood tissue beneath the sensor in any individual < 40kg. 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/K211561
Methodology: https://510kreport.com/methodology