510(k) · Cleared
ClearedMasimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corp. · DQA Oximeter
Cleared on Jun 7, 1999 as substantially equivalent to K973887 (Masimo Corp., 1998) after a 76-day review. Its family tree reaches back 2 generations to 1997. 44 of the 480 devices in its family, counting itself, have a Class I recall. 477 later devices descend from it.
- Decided
- Jun 7, 1999
- Review
- 76 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962603 (1997). 477 later devices descend from it, 10 citing it directly. 44 of the 480 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 1 generation backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- This deviceK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- Descendant · cites it directly · 272 of its ownK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- Descendant · cites it directly · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- Descendant · 4 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
Showing 5 of 477 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 477 · See all- K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc. · 2004 · cites it directly272descendants
- K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · cites it directly264descendants
- K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 2 generations on250descendants
- K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 3 generations on197descendants
- K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 4 generations on170descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −1 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| 0 (this device) | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| +1 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| +1 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| +2 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| +3 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| +4 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 11 | 1 |
| 2007 | 7 | 1 |
| 2008 | 10 | 2 |
| 2009 | 14 | 1 |
| 2010 | 15 | 1 |
| 2011 | 22 | 8 |
| 2012 | 30 | 5 |
| 2013 | 28 | 4 |
| 2014 | 27 | 3 |
| 2015 | 27 | 2 |
| 2016 | 18 | 2 |
| 2017 | 29 | 4 |
| 2018 | 20 | 0 |
| 2019 | 25 | 3 |
| 2020 | 23 | 3 |
| 2021 | 20 | 3 |
| 2022 | 28 | 0 |
| 2023 | 22 | 1 |
| 2024 | 28 | 0 |
| 2025 | 26 | 0 |
| 2026 | 26 | 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.
44 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? (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 |
|---|---|---|---|
| * | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and CablesSummary page 1…r (74DQA) Transducer and Electrode Cable (including connector) (74DSA) Substantially Equivalent Devices: Masimo SET MS-1P Pulse Oximeter and accessories 510(k) Number - K973887 Reason for Submission Premarket notification for Masimo SET® 2000 Pulse Oximeter and accessories, a New Device, seeking authori… | 1998 |
What descends from it? (477)
See all 47710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL… | 2004 | 272 |
| K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS… | 2005 | 264 |
| K021981 | Ivent 201 Portable Ventilator | 2003 | 125 |
| K040595 | ALICE 5 | 2004 | 40 |
| K992238 | Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT, Lnop-Dci… | 1999 | 28 |
| K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric… | 1999 | 21 |
| K061856 | V-2200 Infant Incubator | 2006 | 4 |
| K032403 | Smartmonitor 2 Professional Series (PS) | 2003 | 1 |
| K061071 | V-808 Atom Transcapsule | 2006 | 0 |
| K021135 | Model 2120IS Series Maternal/Fetal Monitor | 2002 | 0 |
Has anything in its family been recalled? (44 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.
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
Nearest 12 of 44 shown.
Nearest 5 of 44; all are on the web page.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033048 (Cas Medical Systems, Inc., 2004) has gone furthest, with 272 descendants of its own.
- 1 other device also cites its predicate K973887.
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 Masimo SET® 2000 Pulse Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate (measured by an SpO, sensor). The Masimo SET® 2000 Pulse Oximeter and accessories are indicated for use with adult, pediatric, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990966
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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