510(k) · Cleared
ClearedMasimo Set Reusable Oximetry Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · DQA Oximeter
Cleared on Feb 24, 2012 as substantially equivalent to K090662 (Masimo Corporation, 2009) after an 81-day review. Its family tree reaches back 16 generations to 1994.
- Decided
- Feb 24, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K941811 (1994). 67 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet.
- Root · 16 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 12 generations between
- 3 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 2 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 1 generation backK090662 Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics…Masimo Corporation · 2009 · Recalled
- This deviceK113596 Masimo Set Reusable Oximetry SensorsMasimo Corporation · 2012
Show all 16 generations
- Root · 16 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 15 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 14 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 13 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 12 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 11 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 10 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 9 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 8 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 7 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 6 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 5 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 4 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 3 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 2 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 1 generation backK090662 Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics…Masimo Corporation · 2009 · Recalled
- This deviceK113596 Masimo Set Reusable Oximetry SensorsMasimo Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −15 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −14 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −13 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −12 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −11 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −10 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −9 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −8 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −7 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −6 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −5 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −4 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −3 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| −2 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
| −1 | K090662 | Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ Dbip | Masimo Corporation | 2009 | 1 |
| 0 (this device) | K113596 | Masimo Set Reusable Oximetry Sensors | Masimo Corporation | 2012 | — |
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 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 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.
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? (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 |
|---|---|---|---|
| * | K090662 | Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipSummary page 1…0.2700 Regulation Name: Pulse Oximeter (Oximetry Sensors) Regulatory Class: Class 11 Product Code DQA Cleared Device: K090662 - Masimo SET Reusable Soft Oximetry Sensors Device Description The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) ha… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 4 of the 67 ancestors have a recall of any class.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate (measured by an SP02 sensor) for use with adult and pediatric patients during no motion conditions, and 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.
https://510kreport.com/device/K113596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113596: Masimo Set Reusable Oximetry Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113596
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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