510(k) · Cleared
ClearedMasimo Disposable Oximetry Ear Sensor, Model E1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Nov 18, 2010 as substantially equivalent to K012992 (Masimo Corp., 2001) and 1 other predicate after a 219-day review. Its family tree reaches back 15 generations to 1994. 5 later devices descend from it.
- Decided
- Nov 18, 2010
- Review
- 219 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K941811 (1994). 68 ancestors in all, the oldest K863784 (1986). 5 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations between
- 3 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 2 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 1 generation backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- This deviceK101031 Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation · 2010
- Descendant · cites it directly · 4 of its ownK121912 E1 Ear SensorsMasimo Corporation · 2012
- Descendant · 2 generations on · 3 of its ownK122996 Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale · 2013
- Descendant · 3 generations on · 2 of its ownK143216 Assurance Alar / Nasal SpO2 SensorXhale, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 1 of its ownK171423 Nasal Alar SpO2 SensorXhale, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 0 of its ownK253887 Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor…Philips Medizin Systeme · 2026
Show all 15 generations
- Root · 15 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 14 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 13 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 12 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 11 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 10 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 9 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 8 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 7 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 6 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 5 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 4 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 2 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 1 generation backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- This deviceK101031 Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation · 2010
Most influential descendants
Showing 5 of 5 · See all- K121912E1 Ear SensorsMasimo Corporation · 2012 · cites it directly4descendants
- K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale · 2013 · 2 generations on3descendants
- K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc. · 2015 · 3 generations on2descendants
- K171423Nasal Alar SpO2 SensorXhale, Inc. · 2017 · 4 generations on1descendant
- K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −14 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −13 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −12 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −11 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −10 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −9 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −8 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −7 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −6 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −5 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −4 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −2 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| −1 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
| 0 (this device) | K101031 | Masimo Disposable Oximetry Ear Sensor, Model E1 | Masimo Corporation | 2010 | — |
| +1 | K121912 | E1 Ear Sensors | Masimo Corporation | 2012 | — |
| +2 | K122996 | Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085 | Xhale | 2013 | — |
| +3 | K143216 | Assurance Alar / Nasal SpO2 Sensor | Xhale, Inc. | 2015 | 1 |
| +4 | K171423 | Nasal Alar SpO2 Sensor | Xhale, Inc. | 2017 | 1 |
| +5 | K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391)… | Philips Medizin Systeme | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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.
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 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? (2)
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 |
|---|---|---|---|
| * | K012992 | Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and CablesSummary page 1…which include or compatible with the following technologies: * Masimo SET technology * Masimo Rainbow SET technology The El Sensors and the predicates (K(012992) Masimo Reuseable Ear Sensor (LNOP Sensor) and (K(051212) the LNCS Reusable Ear Sensor (LNCS Sensor) have similar indications for… | 2001 |
| * | K051212 | Modification to LNCS Oximetry SensorsSummary page 1…lly Equivalent Devices: Masimo Reusable Ear Sensor, 51 0(k) No. 01 2992 LNCS Oximetry Sensors, 510(k) No. K051212 Device Description The Masimo Disposable Ear Oximetry Sensors (El Sensors) are fully compatible for use with instruments which… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121912 | E1 Ear Sensors | 2012 | 4 |
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 16 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 3 of the 68 ancestors have a recall of any class.
- Of its descendants, K121912 (Masimo Corporation, 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K012992.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SPo2 sensor) for use with adult and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101031: Masimo Disposable Oximetry Ear Sensor, Model E1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101031
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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