510(k) · Cleared

Cleared

Tosca PCO2, SPO2 and Pulse Rate Monitoring System

K032291510(k) TraditionalCleared Aug 24, 2004397-day reviewClass II21 CFR 862.3320

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

Linde Medical Sensors AG · DOA Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

Cleared on Aug 24, 2004 as substantially equivalent to K003943 (Linde Medical Sensors AG, 2001) and 1 other predicate after a 397-day review. Its family tree reaches back 1 generation to 1989. 93 later devices descend from it.

Decided: Aug 24, 2004
Review: 397 days
Class: Class II
Product code: DOA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K890299 (1989). 2 ancestors in all. 93 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK890299 Kontron Pulse Oximeter 7840Kontron Instruments, Inc. · 1989
This deviceK032291 Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004
Descendant · cites it directly · 92 of its ownK043357 Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005
Descendant · 2 generations on · 91 of its ownK063434 Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007
Descendant · 3 generations on · 87 of its ownK093154 TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · Recalled
Descendant · 4 generations on · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
Descendant · 5 generations on · 78 of its ownK113441 Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · Recalled

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2005high 12 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 93 · See all

K043357Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005 · cites it directly92descendants
K063434Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007 · 2 generations on91descendants
K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · 3 generations on87descendants
K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 4 generations on84descendants
K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2012 · 5 generations on78descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K890299	Kontron Pulse Oximeter 7840	Kontron Instruments, Inc.	1989	—
0 (this device)	K032291	Tosca PCO2, SPO2 and Pulse Rate Monitoring System	Linde Medical Sensors AG	2004	—
+1	K043357	Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009	Linde Medical Sensors AG	2005	—
+2	K063434	Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring System	Radiometer Basel AG	2007	—
+3	K093154	TCM Tosca Monitoring System, TCM Combim Monitoring System	Radiometer Medical Aps	2010	3
+4	K110474	Philips Intellivue TCG10	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	1
+5	K113441	Physiological Monitor, Patient Monitor	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2012	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2010	2	0
2011	1	0
2012	3	0
2013	5	0
2014	3	0
2015	4	0
2016	2	0
2017	6	0
2018	7	0
2019	6	0
2020	5	0
2021	3	0
2022	7	0
2023	10	0
2024	8	0
2025	12	0
2026	6	0

FIG. 1 — Lineage of K032291, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DOA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K003943	Microgas 7650 Transcutaneous Monitor Summary page 1 …(73LKD) / Oximeter (74DQA) Substantially Equivalent Device: MicroGas 7650 Transcutaneous Monitor (K003943) Kontron Pulse Oximeter 7840 (K890299) D…	Linde Medical Sensors AG	2001	—
*	K890299	Kontron Pulse Oximeter 7840 Summary page 1 …(K003943) Kontron Pulse Oximeter 7840 (K890299) Description of the Tosca PCO2, SpO2 and Pulse Rate Monitoring System The Linde Tosca System is used for the simultaneous conti…	Kontron Instruments, Inc.	1989	—

Also cleared against K003943: 1 other device →

What descends from it? (93)

See all 93

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K043357	Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009	Linde Medical Sensors AG	2005	92

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?

None of the 2 ancestors has a recall.
Of its descendants, K043357 (Linde Medical Sensors AG, 2005) has gone furthest, with 92 descendants of its own.
1 other device also cites its predicate K003943.

How does its category compare?

All DOA devices

DOA Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DOA

FDA has decided no DOA device since 2007.

Median 510(k) review, days · DOA

Too few DOA 510(k)s in any year since 2007 to give a median.

Recalls per year · DOA

1in 2007

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DOA

1in 2019

2007high 1 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	1
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The Linde TOSCA 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.

https://510kreport.com/device/K032291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032291: Tosca PCO2, 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/K032291

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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