510(k) · Cleared
ClearedSPO2.Com Oximetry Sensors, Multiple Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corp. · DQA Oximeter
Cleared on Dec 12, 2003 as substantially equivalent to K031330 (Masimo Corp., 2003) and 2 other predicates after a 59-day review. Its family tree reaches back 4 generations to 1997. 3 of the 104 devices in its family, counting itself, have a Class I recall. 95 later devices descend from it.
- Decided
- Dec 12, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K962603 (1997). 8 ancestors in all, the oldest K863784 (1986). 95 later devices descend from it, 5 citing it directly. 3 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 1 generation backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- This deviceK033298 SPO2.Com Oximetry Sensors, Multiple ModelsMasimo Corp. · 2003
- Descendant · cites it directly · 86 of its ownK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- Descendant · 2 generations on · 85 of its ownK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- Descendant · 3 generations on · 62 of its ownK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- Descendant · 4 generations on · 59 of its ownK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- Descendant · 3 generations on · 39 of its ownK100617 Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 95 · See all- K041815LNCS Oximetry SensorsMasimo Corp. · 2004 · cites it directly86descendants
- K051212Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · 2 generations on85descendants
- K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010 · 3 generations on62descendants
- K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011 · 4 generations on59descendants
- K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation · 2010 · 3 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −1 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| 0 (this device) | K033298 | SPO2.Com Oximetry Sensors, Multiple Models | Masimo Corp. | 2003 | — |
| +1 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| +2 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
| +3 | K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | Masimo Corporation | 2010 | — |
| +4 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | — |
| +3 | K100617 | Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D | Masimo Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 1 |
| 2008 | 2 | 0 |
| 2009 | 5 | 1 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 1 |
| 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.
3 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? (3)
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 |
|---|---|---|---|
| * | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Summary page 1…with SatShareTM and LNOP® series of Sensors ant Cables 510(k) Number - K031330 Nellcor N-395 Pulse Oximeter - K991823… | 2003 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…Cables 510(k) Number - K031330 Nellcor N-395 Pulse Oximeter - K991823 Nellcor N-200 Pulse Oximeter - K863784 Device Description The SPO2.C… | 1999 |
| * | K863784 | Nellcor N-200 (Pulse Oximeter)Summary page 1…0 Nellcor N-395 Pulse Oximeter - K991823 Nellcor N-200 Pulse Oximeter - K863784 Device Description The SPO2.COM Oximetry Sensors are fully compatible disposable and reusable replacement sensors for… | 1986 |
What descends from it? (95)
See all 955 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041815 (Masimo Corp., 2004) has gone furthest, with 86 descendants of its own.
- 13 other devices also cite its predicate K031330.
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 SPO2.COM Sensors and Cables are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SPO2 sensor) for use with adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033298 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033298: SPO2.Com Oximetry Sensors, Multiple Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033298
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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