510(k) Report

510(k) · Cleared

Cleared

Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring System

K063434510(k) TraditionalCleared Jan 22, 200770-day reviewClass II21 CFR 870.2700

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

Radiometer Basel AG · DQA Oximeter

Cleared on Jan 22, 2007 as substantially equivalent to K043357 (Linde Medical Sensors AG, 2005) after a 70-day review. Its family tree reaches back 3 generations to 1989. 91 later devices descend from it.

Decided
Jan 22, 2007
Review
70 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K890299 (1989). 4 ancestors in all. 91 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2010: 2 descendants cleared2007: 1 descendant cleared2024: 8 descendants cleared2015: 4 descendants cleared2011: 1 descendant cleared2017: 6 descendants cleared2012: 3 descendants cleared2014: 3 descendants cleared2013: 5 descendants cleared2016: 2 descendants cleared2023: 10 descendants cleared2020: 5 descendants cleared2022: 7 descendants cleared2018: 7 descendants cleared2019: 6 descendants cleared2021: 3 descendants cleared2025: 12 descendants cleared2026: 6 descendants clearedK890299 · Kontron Pulse Oximeter 7840 · Kontron Instruments, Inc. · 1989K032291 · Tosca PCO2, SPO2 and Pulse Rate Monitoring System · Linde Medical Sensors AG · 2004K043357 · Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009 · Linde Medical Sensors AG · 20051990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 8 descendants4 generations forward: 7 descendants5 generations forward: 18 descendants6 generations forward: 13 descendants7 generations forward: 12 descendants8 generations forward: 7 descendants9 generations forward: 8 descendants10 generations forward: 5 descendants11 generations forward: 6 descendants K043357 · Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009 · Linde Medical Sensors AG · 2005K032291 · Tosca PCO2, SPO2 and Pulse Rate Monitoring System · Linde Medical Sensors AG · 2004K890299 · Kontron Pulse Oximeter 7840 · Kontron Instruments, Inc. · 19890+5+10
  1. Root · 3 generations backK890299 Kontron Pulse Oximeter 7840Kontron Instruments, Inc. · 1989
  2. 2 generations backK032291 Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004
  3. 1 generation backK043357 Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005
  4. This deviceK063434 Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007
  5. Descendant · cites it directly · 87 of its ownK093154 TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · Recalled
  6. Descendant · 2 generations on · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
  7. Descendant · 3 generations on · 78 of its ownK113441 Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · Recalled
  8. Descendant · 3 generations on · 46 of its ownK120366 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012
  9. Descendant · 3 generations on · 41 of its ownK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

2007: 12010: 22011: 12012: 32013: 52014: 32015: 42016: 22017: 62018: 72019: 62020: 52021: 32022: 72023: 102024: 82025: 122026: 6
2007high 12 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 91 · See all
  • K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · cites it directly87descendants
  • K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on84descendants
  • K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 3 generations on78descendants
  • K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 3 generations on46descendants
  • K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · 3 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K890299Kontron Pulse Oximeter 7840Kontron Instruments, Inc.1989—
−2K032291Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG2004—
−1K043357Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG2005—
0 (this device)K063434Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG2007—
+1K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps20103
+2K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN20111
+3K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20121
+3K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012—
+3K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH20124

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201020
201110
201230
201350
201430
201540
201620
201760
201870
201960
202050
202130
202270
2023100
202480
2025120
202660
FIG. 1 — Lineage of K063434, 1989–2026Source: 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), 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. #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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K043357Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009
Summary page 1
…aneous (73LKD) / Oximeter (74DQA) Substantially TOSCA 500 tcPCO2, SPO2 and Pulse Rate Monitoring System Equivalent Device: 510(k) Number: K043357 Description of the TOSCA 500 tcPCO2, SPO2 and Pulse Rate Monitoring System The TOSCA 500 Monitoring System is designed for th…
Linde Medical Sensors AG2005—

What descends from it? (91)

See all 91

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

NumberDeviceApplicantDecidedDescendants
K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps201087
K071672Sentec Digital Monitoring SystemSentec AG20074
K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG20103

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K093154 (Radiometer Medical Aps, 2010) has gone furthest, with 87 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. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

The TOSCA 500 Monitoring System is designed for the simultaneous continuous

monitoring of transcutaneous PCO 2, functional oxygen saturation SPO2 and

Pulse Rate in adults and pediatrics.

Indications for use as stated in the FDA summary.

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/K063434 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063434: Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063434

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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