510(k) · Cleared

Cleared

Kontron Pulse Oximeter 7840

K890299510(k) TraditionalCleared Mar 2, 198942-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

Kontron Instruments, Inc. · DQA Oximeter

Cleared on Mar 2, 1989 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 94 later devices descend from it.

Decided: Mar 2, 1989
Review: 42 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

94 later devices descend from it, 1 citing it directly.

This deviceK890299 Kontron Pulse Oximeter 7840Kontron Instruments, Inc. · 1989
Descendant · cites it directly · 93 of its ownK032291 Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004
Descendant · 2 generations on · 92 of its ownK043357 Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005
Descendant · 3 generations on · 91 of its ownK063434 Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007
Descendant · 4 generations on · 87 of its ownK093154 TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · Recalled
Descendant · 5 generations on · 84 of its ownK110474 Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled

Showing 5 of 94 descendants. See all descendants

Descendants cleared per year

2004high 12 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 94 · See all

K032291Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemLinde Medical Sensors AG · 2004 · cites it directly93descendants
K043357Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009Linde Medical Sensors AG · 2005 · 2 generations on92descendants
K063434Tosca 500 TCPCO2, SPO2 and Pulse Rate Monitoring SystemRadiometer Basel AG · 2007 · 3 generations on91descendants
K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemRadiometer Medical Aps · 2010 · 4 generations on87descendants
K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 5 generations on84descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
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 K890299, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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? (94)

See all 94

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

Number	Device	Applicant	Decided	Descendants
K032291	Tosca PCO2, SPO2 and Pulse Rate Monitoring System	Linde Medical Sensors AG	2004	93

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?

Of its descendants, K032291 (Linde Medical Sensors AG, 2004) has gone furthest, with 93 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

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

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

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

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	—

https://510kreport.com/device/K890299 · printed Nov 4, 2026

Cite this page

510(k) Report. “K890299: Kontron Pulse Oximeter 7840.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890299

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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