510(k) Report

510(k) · Cleared

Recalled · 2009

Modification to MARSPO2, Model 2001

K000794510(k) SpecialCleared Apr 10, 200028-day reviewClass II21 CFR 870.2700Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Novametrix Medical Systems, Inc. · DQA Oximeter

Cleared on Apr 10, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 248 later devices descend from it. It has been recalled 5 times.

Decided
Apr 10, 2000
Review
28 days
Class
Class II
Product code
DQA
Recalls
5
Predicates
0

248 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2003: 1 descendant cleared2006: 9 descendants cleared2008: 6 descendants cleared2005: 1 descendant cleared2009: 7 descendants cleared2010: 7 descendants cleared2007: 3 descendants cleared2012: 9 descendants cleared2011: 9 descendants cleared2013: 12 descendants cleared2015: 7 descendants cleared2018: 14 descendants cleared2014: 10 descendants cleared2016: 11 descendants cleared2017: 12 descendants cleared2023: 22 descendants cleared2019: 11 descendants cleared2021: 13 descendants cleared2025: 23 descendants cleared2022: 18 descendants cleared2020: 9 descendants cleared2026: 13 descendants cleared2024: 18 descendants cleared200020052010201520202025
  1. This deviceK000794 Modification to MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 2000
  2. Descendant · cites it directly · 246 of its ownK030886 Nico with Mars, Model 7300Respironics Novametrix, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 233 of its ownK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
  4. 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
  5. 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
  6. Descendant · 3 generations on · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006

Showing 5 of 248 descendants. See all descendants

Descendants cleared per year

2003: 12004: 32005: 12006: 92007: 32008: 62009: 72010: 72011: 92012: 92013: 122014: 102015: 72016: 112017: 122018: 142019: 112020: 92021: 132022: 182023: 222024: 182025: 232026: 13
2003high 23 (2025) · low 1 (2003)2026

Most influential descendants

Showing 5 of 248 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000794Modification to MARSPO2, Model 2001Novametrix Medical Systems, Inc.2000—
+1K030886Nico with Mars, Model 7300Respironics Novametrix, Inc.20038
+2K053522Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors…Philips Medizin Systeme Boeblingen GmbH2006—
+3K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH2006—
+3K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…Philips Medizin Systeme Boblingen GmbH20062
+3K061052The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200430
200510
200690
200730
200860
200970
201070
201190
201290
2013120
2014100
201570
2016110
2017120
2018140
2019110
202090
2021130
2022180
2023220
2024180
2025230
2026130
FIG. 1 — Lineage of K000794, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (248)

See all 248

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030886Nico with Mars, Model 7300Respironics Novametrix, Inc.2003246
K032755Model 509M Pulse Oximeter, Model 509MRespironics Novametrix, Inc.20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2009Not classifiedZ-1304-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1303-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1308-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Nov 19, 2009Not classifiedZ-1302-2010Nonconforming Material/ComponentPower cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may…
Sep 2, 2002Not classifiedZ-1049-04OtherAudio 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?

  • Of its descendants, K030886 (Respironics Novametrix, Inc., 2003) has gone furthest, with 246 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

More from Novametrix Medical Systems, Inc.

58 FDA decisions under this applicant name. See the company

  • K010451Novametrix Marquette Compatible SensorsNovametrix Medical Systems, Inc. · 2001
  • K993979MARSPO2, Model 2001Novametrix Medical Systems, Inc. · 20001 recall
  • K982499Cosmo Plus with Nico, Model 8200Novametrix Medical Systems, Inc. · 19981 recall
  • K964360Vent (Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101Novametrix Medical Systems, Inc. · 1997
  • K963380CO 2 Smo PlusNovametrix Medical Systems, Inc. · 19973 recalls

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K000794 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000794: Modification to MARSPO2, Model 2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000794

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026