510(k) · Cleared

Recalled · 2009

Apex Oximeter

K980299510(k) TraditionalCleared Apr 24, 199887-day reviewClass II21 CFR 870.2700Recalls 1

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

Marquette Medical Systems, Inc. · DQA Oximeter

Cleared on Apr 24, 1998 as substantially equivalent to K893221 (Nonin Medical, Inc., 1990) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled once.

Decided: Apr 24, 1998
Review: 87 days
Class: Class II
Product code: DQA
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K891104 (1989). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
This deviceK980299 Apex OximeterMarquette Medical Systems, Inc. · 1998
Descendant · cites it directly · 1 of its ownK080251 Apexpro Telemetry SystemsGe Medical Systems Information Technologies · 2008 · Recalled
Descendant · 2 generations on · 0 of its ownK160685 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K080251Apexpro Telemetry SystemsGe Medical Systems Information Technologies · 2008 · cites it directly1descendant
K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K891104	CD Telemetry Systems	Marquette Electronics, Inc.	1989	—
0 (this device)	K980299	Apex Oximeter	Marquette Medical Systems, Inc.	1998	—
+1	K080251	Apexpro Telemetry Systems	Ge Medical Systems Information Technologies	2008	4
+2	K160685	Surveyor S4 Mobile Monitor	Mortara Instrument, Inc.	2016	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2016	1	0

FIG. 1 — Lineage of K980299, 1989–2016Source: 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 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? (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	Applicant	Decided	Recalls
*	K893221	Model 8500 Hand Held Pulse Oximeter Summary page 2 …proposed modified device, the APEX OXIMETER, is substantially equivalent to devices already in legal commercial distribution: Nonin Model 8500 Hand Held Pulse Oximeter (K893221); Nonin Model 9500 Finger Clip Pulse Oximeter (K942248); Marquette CD Telemetry System (K891104). 4. Device Description and Inte…	Nonin Medical, Inc.	1990	1
*	K942248	Miniaturized Finger Clip Pulse Oximeter Summary page 2 …ntially equivalent to devices already in legal commercial distribution: Nonin Model 8500 Hand Held Pulse Oximeter (K893221); Nonin Model 9500 Finger Clip Pulse Oximeter (K942248); Marquette CD Telemetry System (K891104). 4. Device Description and Intended Use This device is viewed as a component of a sys…	Nonin Medical, Inc.	1994	—
*	K891104	CD Telemetry Systems Summary page 2 …legal commercial distribution: Nonin Model 8500 Hand Held Pulse Oximeter (K893221); Nonin Model 9500 Finger Clip Pulse Oximeter (K942248); Marquette CD Telemetry System (K891104). 4. Device Description and Intended Use This device is viewed as a component of a system. The APEX OXIMETER adds modularity to…	Marquette Electronics, Inc.	1989	—

Also cleared against K893221: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K080251	Apexpro Telemetry Systems	Ge Medical Systems Information Technologies	2008	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 25, 2009	Not classified	Z-0631-2010	Labeling design	Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with SpO2 oximeters: 1. ApexPro FH…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K080251 (Ge Medical Systems Information Technologies, 2008) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K893221.

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	—

What is it indicated for?

This device is viewed as a component of a system. The APEX Oximeter adds modularity to Marquette's CD Telemetry System product line. The Apex Oximeter is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate.

This device is infended to be used by personnel trained in the use of the equipment. It is infended to be used within the hospital/facility environment.

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/K980299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980299: Apex Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980299

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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