510(k) · Cleared
Recalled · Class II · 2024Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Sep 24, 2020 as substantially equivalent to K193242 (Masimo Corporation, 2020) after an 87-day review. Its family tree reaches back 23 generations to 1997. 2 of the 97 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Sep 24, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 23 generations to K962603 (1997). 95 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly. 2 of the 97 devices in this family, counting this one, have a Class I recall.
- Root · 23 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 19 generations between
- 3 generations backK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
- 2 generations backK183697 Masimo Rad-97 and AccessoriesMasimo Corporation · 2019
- 1 generation backK193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7…Masimo Corporation · 2020
- This deviceK201770 Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G…Masimo Corporation · 2020
- Descendant · cites it directly · 0 of its ownK231531 Pediarity™Hinlab, Inc. · 2023
Show all 23 generations
- Root · 23 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 22 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 21 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 20 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 19 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 18 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 17 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 16 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 15 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 14 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 13 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 12 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 11 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 10 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 9 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 8 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 7 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 6 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 5 generations backK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
- 4 generations backK170168 Masimo Rad-97 and AccessoriesMasimo Corporation · 2017
- 3 generations backK180046 Masimo Rad-97 and AccessoriesMasimo Corporation · 2018 · Recalled
- 2 generations backK183697 Masimo Rad-97 and AccessoriesMasimo Corporation · 2019
- 1 generation backK193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7…Masimo Corporation · 2020
- This deviceK201770 Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G…Masimo Corporation · 2020
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K231531Pediarity™Hinlab, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −22 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −21 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −20 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −19 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −18 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −17 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −16 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −15 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −14 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −13 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −12 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −11 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −10 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −9 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −8 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −7 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −6 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −5 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
| −4 | K170168 | Masimo Rad-97 and Accessories | Masimo Corporation | 2017 | — |
| −3 | K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018 | 1 |
| −2 | 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 | — |
| 0 (this device) | K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable… | Masimo Corporation | 2020 | — |
| +1 | K231531 | Pediarity™ | Hinlab, Inc. | 2023 | — |
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 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Summary page 4…3011353843 Number: Reason for Premarket New Device Notification: Predicate Device: Masimo Radical-7 Pulse Co-Oximeter and Accessories (K193242) Reference Predicate Masimo MightySat Rx Fingertip Pulse Oximeter (K181956) Performance Standards No pe… | 2020 |
| † | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231531 | Pediarity™ | 2023 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2024 | Class II | Z-1538-2024 | Material/Component Contamination | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| Feb 15, 2024 | Class II | Z-1537-2024 | Material/Component Contamination | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
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 23 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 21 of the 95 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K231531 (Hinlab, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K193242.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and…
Read the full statement (126 words)
The Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of
functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp).
The Rad-G Pulse Oximeter and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments.
The Rad-G Pulse Oximeter and Accessories are indicated for the spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201770 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201770: Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201770
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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