510(k) · Cleared
Recalled · 2002MARSPO2, Model 2001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novametrix Medical Systems, Inc. · DQA Oximeter
Cleared on Feb 22, 2000 as substantially equivalent to K913516 (Novametrix Medical Systems, Inc., 1991) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1997. 255 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K962603 (1997). 6 ancestors in all, the oldest K913516 (1991). 255 later devices descend from it, 4 citing it directly.
- 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 deviceK993979 MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000
- Descendant · cites it directly · 246 of its ownK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 3 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 3 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- Descendant · 3 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
Showing 5 of 255 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 255 · See all- K030886Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · cites it directly246descendants
- K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on233descendants
- K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 3 generations on222descendants
- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 3 generations on221descendants
- K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · 3 generations on211descendants
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) | K993979 | MARSPO2, Model 2001 | Novametrix Medical Systems, Inc. | 2000 | — |
| +1 | K030886 | Nico with Mars, Model 7300 | Respironics Novametrix, Inc. | 2003 | 8 |
| +2 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +3 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +3 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| +3 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 13 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 22 | 0 |
| 2024 | 19 | 0 |
| 2025 | 23 | 0 |
| 2026 | 13 | 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? (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 |
|---|---|---|---|
| * | K913516 | Model 520A Novametrix Pulse OximeterSummary page 1…r currently published accuracy specifications with the Model 2001. The predicate devices are as follows: 1. Model 520A Pulse Oximeter, Novametrix Medical Systems, Inc., K913516 2. Model 2000 Puise Oximeter, Ivy Biomedical Systems, Inc., K982255 3. N-395 Pulse Oximeter, Nellcor Puritan Bennett Inc., K99182… | 1991 |
| * | K982255 | Model 2000 Pulse OximeterSummary page 1…he predicate devices are as follows: 1. Model 520A Pulse Oximeter, Novametrix Medical Systems, Inc., K913516 2. Model 2000 Puise Oximeter, Ivy Biomedical Systems, Inc., K982255 3. N-395 Pulse Oximeter, Nellcor Puritan Bennett Inc., K991823 e. Device Description The Model 2001 Pulse Oximeter is designed… | 1998 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…ter, Novametrix Medical Systems, Inc., K913516 2. Model 2000 Puise Oximeter, Ivy Biomedical Systems, Inc., K982255 3. N-395 Pulse Oximeter, Nellcor Puritan Bennett Inc., K991823 e. Device Description The Model 2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of the functional oxyge… | 1999 |
What descends from it? (255)
See all 2554 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2002 | Not classified | Z-1049-04 | Other | Audio alarm may fail to sound when SpO2 limits drop below the set limits |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K030886 (Respironics Novametrix, Inc., 2003) has gone furthest, with 246 descendants of its own.
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 Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate units in neonatal, pediatric and adult patients in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.
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/K993979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993979: MARSPO2, Model 2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993979
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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