510(k) · Cleared
ClearedMasimo Rad-97 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 May 15, 2019 as substantially equivalent to K180046 (Masimo Corporation, 2018) after a 135-day review. Its family tree reaches back 21 generations to 1997. 2 of the 102 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- May 15, 2019
- Review
- 135 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K962603 (1997). 92 ancestors in all, the oldest K853990 (1985). 9 later devices descend from it, 2 citing it directly. 2 of the 102 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 17 generations between
- 3 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 2 generations backK170168 Masimo Rad-97 and AccessoriesMasimo Corporation · 2017
- 1 generation backK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
- This deviceK183697 Masimo Rad-97 and AccessoriesMasimo Corporation · 2019
- Descendant · cites it directly · 7 of its ownK193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7…Masimo Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK223498 Radius VSM and AccessoriesMasimo Corporation · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK201770 Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G…Masimo Corporation · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK193626 Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK253196 Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200…Midmark Corporation · 2026
Show all 21 generations
- Root · 21 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 20 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 19 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 18 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 17 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 16 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 15 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 14 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 13 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 12 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 11 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 10 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 9 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 8 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 7 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 6 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 5 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 4 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 3 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 2 generations backK170168 Masimo Rad-97 and AccessoriesMasimo Corporation · 2017
- 1 generation backK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
- This deviceK183697 Masimo Rad-97 and AccessoriesMasimo Corporation · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation · 2020 · cites it directly7descendants
- K223498Radius VSM and AccessoriesMasimo Corporation · 2023 · 2 generations on1descendant
- K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation · 2020 · 2 generations on1descendant
- K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation · 2020 · cites it directly1descendant
- K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −20 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −19 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −18 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −17 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −16 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −15 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −14 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −13 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −12 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −11 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −10 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −9 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −8 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −7 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −6 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −5 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −4 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −3 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| −2 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | — |
| −1 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 1 |
| 0 (this device) | K183697 | Masimo Rad-97 and Accessories | Masimo Corporation | 2019 | — |
| +1 | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse… | Masimo Corporation | 2020 | — |
| +2 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 2 |
| +2 | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable… | Masimo Corporation | 2020 | 2 |
| +1 | K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2020 | — |
| +2 | K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300… | Midmark Corporation | 2026 | — |
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 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 1 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K180046 | Masimo Rad-97 and AccessoriesSummary page 5…lass II/FLL Establishment Registration 2031172 Number: Reason for Premarket New Device Notification: Predicate Device: K180046 – Masimo Rad-97 and Accessories Reference Predicate: K153225 – Masimo Root Monitoring System and Accessories Pe… | 2018 |
| † | K153225 | Masimo Root Monitoring System and Accessories | 2016 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 21 of the 92 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K193242 (Masimo Corporation, 2020) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K180046.
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. 2019, 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 Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi parameter devices for the display on those devices. The…
Read the full statement (539 words)
The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and
alarming (e.g., at a central station). In addition, the Masimo Rad-97 and Accessories are indicated to provide the
continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi parameter devices for the display on those devices.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin
saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type
facilities. The Masimo Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or
treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with
additional methods of assessing clinical signs and symptoms.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin
saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type
facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin
concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa)
for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home
environments, and transport within healthcare facilities.
The optional Nomoline Capnography product family is intended to be connected to other medical backboard devices for
monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to be connected to a patient
breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The
environment is the operating suite, intensive care unit and patient room. The intended patient population is adult, pediatric
and infant patients.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood
pressure in hospitals, hospital-type facilities, mobile, and home environments. The NIBP module is designed to measure
blood pressure for patient population described in the following table:
Patient Population Approximate Age Range
Newborn (neonate) Birth to 1 month of age
Infant 1 month to 2 years of age
Child 2 to 12 years of age
Adolescent 12-21 years of age
Adult 21 years of age and older
The optional Masimo Centroid O2 is intended for the non-invasive continuous monitoring of functional oxygen saturation
of arterial hemoglobin (SpO2) and pulse rate (PR).
The optional Masimo Centroid O2 is indicated for the continuous monitoring of functional arterial oxygen saturation of
hemoglobin (SpO2) and pulse rate (PR) 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 hospital, hospital-type facilities and home
environments.
Devices with Masimo technology are only to be used with Masimo sensors and cables.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183697: Masimo Rad-97 and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183697
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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