510(k) Report

510(k) · Cleared

Cleared

Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8

K092838510(k) SpecialCleared Oct 15, 200930-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Masimo Corporation · DQA Oximeter

Cleared on Oct 15, 2009 as substantially equivalent to K053269 (Masimo Corporation, 2005) after a 30-day review. Its family tree reaches back 4 generations to 2000. 38 later devices descend from it.

Decided
Oct 15, 2009
Review
30 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K000126 (2000). 38 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared2016: 2 descendants cleared2018: 4 descendants cleared2017: 2 descendants cleared2019: 4 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2022: 3 descendants cleared2023: 6 descendants cleared2026: 4 descendants cleared2025: 6 descendants cleared2024: 1 descendant clearedK000126 · Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia · Masimo Corp. · 2000K031330 · Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 2003K033296 · Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V · Masimo Corp. · 2004 · recalledK053269 · Masimo Set Rad-8 Pulse Oximeter · Masimo Corporation · 2005200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 12 descendants5 generations forward: 7 descendants6 generations forward: 7 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants K053269 · Masimo Set Rad-8 Pulse Oximeter · Masimo Corporation · 2005K033296 · Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V · Masimo Corp. · 2004 · recalledK031330 · Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables · Masimo Corp. · 2003K000126 · Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop-Adt-Adult/Pediatric Disposable Sensor, Masimo Lno-PDT-Pedia · Masimo Corp. · 20000+5
  1. Root · 4 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
  2. 3 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
  3. 2 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
  4. 1 generation backK053269 Masimo Set Rad-8 Pulse OximeterMasimo Corporation · 2005
  5. This deviceK092838 Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8Masimo Corporation · 2009
  6. Descendant · cites it directly · 37 of its ownK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
  7. Descendant · 2 generations on · 34 of its ownK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
  8. Descendant · 3 generations on · 31 of its ownK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
  9. Descendant · 4 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
  10. Descendant · 4 generations on · 6 of its ownK221704 HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP)…Edwards Lifesciences, LLC · 2022

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 22016: 22017: 22018: 42019: 42020: 12021: 12022: 32023: 62024: 12025: 62026: 4
2012high 6 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 38 · See all
  • K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012 · cites it directly37descendants
  • K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH · 2015 · 2 generations on34descendants
  • K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH · 2016 · 3 generations on31descendants
  • K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 4 generations on8descendants
  • K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC · 2022 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K000126Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp.2000—
−3K031330Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop…Masimo Corp.2003—
−2K033296Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse…Masimo Corp.20041
−1K053269Masimo Set Rad-8 Pulse OximeterMasimo Corporation2005—
0 (this device)K092838Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8Masimo Corporation2009—
+1K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation2012—
+2K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH20151
+3K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH20161
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue…Philips Medizin Systeme Boeblingen GmbH20174
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global…Edwards Lifesciences, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201520
201620
201720
201840
201940
202010
202110
202230
202360
202410
202560
202640
FIG. 1 — Lineage of K092838, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DQA? 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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K053269Masimo Set Rad-8 Pulse Oximeter
Summary page 1
…Oximeter (74DQA) (870.2700) Substantially Equivalent Devices Masimo SET® Rad 8 Pulse Oximeter 510(k) Number- K053269 Device Description The Masimo SET® Rad-8 Pulse Oximeter and Accessories (Rad 8) have the following features and benefits:…
Masimo Corporation2005—

Also cleared against K053269: 4 other devices →

What descends from it? (38)

See all 38

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K120657 (Masimo Corporation, 2012) has gone furthest, with 37 descendants of its own.
  • 4 other devices also cite its predicate K053269.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPO2 sensor). The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

Indications for use as stated in the FDA summary.

Also cleared against K053269

4 other devices cite the same predicate.

  • K1809033880 MRI Patient Monitoring SystemIradimed Corporation · 2019
  • K131876M Series Patient MonitorMid-Link Consulting Co, Ltd. · 2014
  • K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd. · 2010
  • K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co. · 2006

More from Masimo Corporation

88 FDA decisions under this applicant name. See the company

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K253417Masimo Root Monitoring SystemMasimo Corporation · 2026
  • K260880SedLine Sedation MonitorMasimo Corporation · 2026
  • K254209Radius VSM and AccessoriesMasimo Corporation · 2026
  • K243324Masimo O3 Regional OximeterMasimo Corporation · 2025

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K092838 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092838: Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092838

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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