510(k) · Cleared
ClearedMasimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corp. · DQA Oximeter
Cleared on Jan 8, 1998 as substantially equivalent to K962603 (Masimo Corp., 1997) after an 86-day review. Its family tree reaches back 1 generation to 1997. 47 of the 1,002 devices in its family, counting itself, have a Class I recall. 1,000 later devices descend from it.
- Decided
- Jan 8, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962603 (1997). 1,000 later devices descend from it, 2 citing it directly. 47 of the 1,002 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- This deviceK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- Descendant · cites it directly · 816 of its ownK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- Descendant · 2 generations on · 785 of its ownK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- Descendant · 2 generations on · 715 of its ownK993637 N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 548 of its ownK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- Descendant · cites it directly · 477 of its ownK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
Showing 5 of 1,000 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,000 · See all- K982255Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998 · cites it directly816descendants
- K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999 · 2 generations on785descendants
- K993637N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · 2 generations on715descendants
- K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Nellcor Puritan Bennett, Inc. · 2002 · 3 generations on548descendants
- K990966Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Masimo Corp. · 1999 · cites it directly477descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| 0 (this device) | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| +1 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| +2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| +2 | K993637 | N-395 Pulse Oximeter, with Extended Device Claims | Nellcor Puritan Bennett, Inc. | 1999 | 1 |
| +3 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| +1 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 13 | 0 |
| 2003 | 14 | 0 |
| 2004 | 26 | 0 |
| 2005 | 20 | 0 |
| 2006 | 37 | 1 |
| 2007 | 17 | 2 |
| 2008 | 33 | 2 |
| 2009 | 45 | 2 |
| 2010 | 42 | 1 |
| 2011 | 50 | 8 |
| 2012 | 52 | 5 |
| 2013 | 47 | 5 |
| 2014 | 43 | 3 |
| 2015 | 52 | 2 |
| 2016 | 41 | 2 |
| 2017 | 47 | 4 |
| 2018 | 45 | 0 |
| 2019 | 52 | 3 |
| 2020 | 43 | 3 |
| 2021 | 33 | 3 |
| 2022 | 48 | 0 |
| 2023 | 49 | 1 |
| 2024 | 45 | 0 |
| 2025 | 57 | 0 |
| 2026 | 41 | 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.
47 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 |
|---|---|---|---|
| * | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesSummary page 1…imeter and Sensor Oximeter (74DQA) (870.2700) Cable, Transducer and Electrode (74DSA) (870.2900) Devices Masimo SET MS-1 Pulse Oximeter and accessories 510(k) Number - K962603 Description of Masimo SET® MS-1P Pulse Oximeter The Masimo SET® MS-1P pulse oximeter and accessories is a device consisting of… | 1997 |
What descends from it? (1,000)
See all 1,0002 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (47 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 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 4 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 5 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 · 5 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 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
Nearest 12 of 47 shown.
Nearest 5 of 47; all are on the web page.
What does this lineage say?
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?
Masimo SET® MS-1P Pulse Oximeter and the LNOP® Series of Sensors and PC Series of Patient Cables are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO,) and pulse rates during both no motion and patient motion conditions for adult, pediatric, and neonatal patients in a hospital and mobile environment. The Masimo LNOP® Series of Sensors are indicated for the following: A single use oximetry sensor intended for adults…
Read the full statement (159 words)
Masimo SET® MS-1P Pulse Oximeter and the LNOP® Series of Sensors and PC Series of Patient Cables are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO,) and pulse rates during both no motion and patient motion conditions for adult, pediatric, and neonatal patients in a hospital and mobile environment.
The Masimo LNOP® Series of Sensors are indicated for the following:
A single use oximetry sensor intended for adults and pediatrics greater than 30 kg
A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
A single use oximetry sensor intended for neonates greater than 2,000 gms
A single use oximetry sensor intended for neonates less than 2,000 gms
A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® MS-1P Pulse Oximeter.
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/K973887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973887: Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973887
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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