510(k) · Cleared
Recalled · Class II · 2024INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · MUD Oximeter, Tissue Saturation
Cleared on Dec 5, 2021 as substantially equivalent to K082327 (Somanetics Corp., 2009) and 2 other predicates after a 199-day review. Its family tree reaches back 5 generations to 2000. It has been recalled once.
- Decided
- Dec 5, 2021
- Review
- 199 days
- Class
- Class II
- Product code
- MUD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001842 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
- 4 generations backK051274 Invos SystemSomanetics Corp. · 2005
- 3 generations backK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
- 2 generations backK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
- 1 generation backK091224 Oxyalert Nirsensors, Accessories for Invos 5100C System, Models…Somanetics Corp. · 2009
- This deviceK211561 INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS…Covidien, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100 | Somanetics Corp. | 2000 | — |
| −4 | K051274 | Invos System | Somanetics Corp. | 2005 | — |
| −3 | K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100C | Somanetics Corp. | 2008 | — |
| −2 | K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100C | Somanetics Corp. | 2009 | — |
| −1 | K091224 | Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-S | Somanetics Corp. | 2009 | — |
| 0 (this device) | K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant… | Covidien, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUD device
- #1 K223651 Cerebral Adaptive Index (CAI) Algorithmscore 19.8 · 29 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100CSummary page 4…DEVICE: Manuf acturer: Covidien llc Device Name: INVOS™ Cerebral/Somatic Oximeter System, Model 5100C 510(k) Number: K082327 Clearance Date: April 3, 2009 ADDITIONAL PREDICATE DEVICE: Manuf acturer: Covidien llc D… | 2009 |
| * | K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 SensorSummary page 4…ADDITIONAL PREDICATE DEVICE: Manuf acturer: Covidien llc Device Name: INVOS™ PM7100 Patient Monitor 510(k) Number: K182868 Clearance Date: January 8, 2019 Page… | 2019 |
| * | K091224 | Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-SSummary page 5…Covidien llc Device Name: OxyAlert Infant/Neonatal Somatic NIR Sensor Model IS-S 510(k) Number: K091224 Clearance Date: July 9, 2009 ADDITIONAL PREDICATE DEVICE: Manuf acturer:… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2024 | Class II | Z-1731-2024 | Process design | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 9 other devices also cite its predicate K082327.
How does its category compare?
All MUD devicesMUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MUD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUD
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUD
131in 2025
MAUDE reports naming product code MUD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 4 | 72 | 0 | 2 |
| 2009 | 4 | 96 | 1 | 7 |
| 2010 | 4 | 59 | 0 | 1 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 6 | 211 | 0 | 3 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 5 | 109 | 0 | 4 |
| 2015 | 3 | 107 | 0 | 0 |
| 2016 | 4 | 167 | 0 | 9 |
| 2017 | 3 | 249 | 0 | 24 |
| 2018 | 3 | 128 | 0 | 38 |
| 2019 | 7 | 88 | 0 | 107 |
| 2020 | 2 | — | 0 | 50 |
| 2021 | 2 | — | 0 | 27 |
| 2022 | 2 | — | 2 | 52 |
| 2023 | 2 | — | 1 | 73 |
| 2024 | 5 | 124 | 0 | 140 |
| 2025 | 2 | — | 0 | 131 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (288 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211561: INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211561
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026