510(k) · Cleared
Recalled · Class II · 2023Modification to LNCS 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 Jul 12, 2005 as substantially equivalent to K041815 (Masimo Corp., 2004) and 2 other predicates after a 62-day review. Its family tree reaches back 14 generations to 1994. 85 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 12, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 14 generations to K941811 (1994). 65 ancestors in all, the oldest K863784 (1986). 85 later devices descend from it, 12 citing it directly.
- Root · 14 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 10 generations between
- 3 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 1 generation backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- This deviceK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005
- Descendant · cites it directly · 62 of its ownK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- Descendant · 2 generations on · 59 of its ownK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- Descendant · cites it directly · 39 of its ownK100617 Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010
- Descendant · 2 generations on · 38 of its ownK111621 Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS…Masimo Corporation · 2011
- Descendant · cites it directly · 37 of its ownK120657 Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012
Show all 14 generations
- Root · 14 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 13 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 12 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 11 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 10 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 9 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 8 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 7 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 6 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 5 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 4 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 3 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 2 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 1 generation backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- This deviceK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010 · cites it directly62descendants
- K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011 · 2 generations on59descendants
- K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010 · cites it directly39descendants
- K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation · 2011 · 2 generations on38descendants
- K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation · 2012 · cites it directly37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −13 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −12 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −11 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −10 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −9 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −8 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −7 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −6 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −5 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −4 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −3 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −2 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −1 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| 0 (this device) | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | — |
| +1 | K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | Masimo Corporation | 2010 | — |
| +2 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | — |
| +1 | K100617 | Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D | Masimo Corporation | 2010 | — |
| +2 | K111621 | Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry… | Masimo Corporation | 2011 | — |
| +1 | K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 12 | 0 |
| 2026 | 7 | 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? (4)
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 |
|---|---|---|---|
| * | K041815 | LNCS Oximetry SensorsSummary page 1…4DPZ) (870.2710) Substantially Equivalent Devices: LNCS Oximetry Sensors 510(k) Number - K(041815 510(k) Number - K(0332… | 2004 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors Nelicor N-395 Pulse Oximeter - K(991823 Nelicor N-200 Pulse Oximeter - K(863784 Device Description… | 1999 |
| * | K863784 | Nellcor N-200 (Pulse Oximeter)Summary page 1…Nelicor N-395 Pulse Oximeter - K(991823 Nelicor N-200 Pulse Oximeter - K(863784 Device Description… | 1986 |
| * | — | SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors Named without a submission number |
What descends from it? (85)
See all 8512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | 2010 | 62 |
| K100617 | Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D | 2010 | 39 |
| K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors | 2012 | 37 |
| K060143 | LNCS and SPO2.Com Sensors | 2006 | 10 |
| K101031 | Masimo Disposable Oximetry Ear Sensor, Model E1 | 2010 | 5 |
| K083719 | LNCS Oximetry Sensors | 2009 | 2 |
| K090662 | Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ Dbip | 2009 | 1 |
| K083622 | LNCS Oximetry Sensors | 2009 | 1 |
| K080424 | Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and… | 2008 | 1 |
| K102560 | Reprocessed Pulse Oximeter Sensors | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2023 | Class II | Z-1986-2023 | Nonconforming Material/Component | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| Apr 21, 2023 | Class II | Z-1985-2023 | Nonconforming Material/Component | TC-I tip clip sensor may produce readings outside the accuracy specification. |
| Apr 4, 2016 | Class II | Z-2641-2017 | Component change control | Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care. |
| Apr 4, 2016 | Class II | Z-2640-2017 | Component change control | Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care. |
| Apr 4, 2016 | Class II | Z-2642-2017 | Component change control | Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 2 of the 65 ancestors have a recall of any class.
- Of its descendants, K101896 (Masimo Corporation, 2010) has gone furthest, with 62 descendants of its own.
- 8 other devices also cite its predicate K041815.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 LNCS Sensors are indicated for the continuous noninvasive monitoring of functional-oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051212: Modification to LNCS 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/K051212
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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