510(k) · Cleared
ClearedMasimo Root Monitoring System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 21, 2016 as substantially equivalent to K142394 (Masimo Corporation, 2014) after a 228-day review. Its family tree reaches back 18 generations to 1997. 1 of the 79 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 21, 2016
- Review
- 228 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K962603 (1997). 78 ancestors in all, the oldest K853990 (1985). No later device cites it as a predicate yet. 1 of the 79 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 14 generations between
- 3 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 2 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 1 generation backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- This deviceK153225 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2016
Show all 18 generations
- Root · 18 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 17 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 16 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 15 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 14 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 13 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 12 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 11 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 10 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 9 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 8 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 7 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 6 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 5 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 4 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 3 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 2 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 1 generation backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- This deviceK153225 Masimo Root Monitoring System and AccessoriesMasimo Corporation · 2016
Class I recalls in this family
- K970209 Capnocheck Plus10 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −17 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −16 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −15 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −14 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −13 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −12 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −11 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −10 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −9 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −8 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −7 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −6 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −5 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −4 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −3 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −2 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −1 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| 0 (this device) | K153225 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 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.
1 device in this family has a Class I recall. 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K142394 | Masimo Root Monitoring System and AccesoriesSummary page 5…2031172 Number: Reason for Premarket Device modification and new indications for use Notification: Predicate Devices: K142394 – Masimo Root Monitoring System and Accessories Performance Standards No perform… | 2014 |
| † | K110028 | Masimo Radical Y Pulse CO-Oximeter | 2011 |
| † | K103604 | Isa CO2, Isa AX+, Isa or+ | 2011 |
| † | K051874 | Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose Set | 2005 |
| † | K071047 | Masimo Patient Safety Net | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 10 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 15 of the 78 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K142394.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System and Accessories can transmit data for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of…
Read the full statement (438 words)
The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.
The Masimo Root Monitoring System and Accessories can transmit data for supplemental remote viewing and alarming (e.g., at a central station).
The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:
ISA CO2: CO2
ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.
The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153225: Masimo Root Monitoring System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153225
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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