510(k) · Cleared

Cleared

Modular Telemetry System (MTS) Option for the Mde Escort II Monitor

K970763510(k) TraditionalCleared Jul 14, 1997133-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

Cleared on Jul 14, 1997 after a 133-day review. The FDA summary names its predicate without a number. 171 later devices descend from it.

Decided: Jul 14, 1997
Review: 133 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 0

171 later devices descend from it, 4 citing it directly.

This deviceK970763 Modular Telemetry System (MTS) Option for the Mde Escort II MonitorMedical Data Electronics · 1997
Descendant · cites it directly · 124 of its ownK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
Descendant · 2 generations on · 89 of its ownK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
Descendant · 3 generations on · 75 of its ownK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
Descendant · 2 generations on · 42 of its ownK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
Descendant · 4 generations on · 40 of its ownK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008

Showing 5 of 171 descendants. See all descendants

Descendants cleared per year

2002high 16 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 171 · See all

K013319Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) MonitorNonin Medical, Inc. · 2002 · cites it directly124descendants
K041156Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · 2 generations on89descendants
K0433594100 Patient Oximeter ModuleNonin Medical, Inc. · 2005 · 3 generations on75descendants
K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004 · 2 generations on42descendants
K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008 · 4 generations on40descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970763	Modular Telemetry System (MTS) Option for the Mde Escort II Monitor	Medical Data Electronics	1997	—
+1	K013319	Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor	Nonin Medical, Inc.	2002	—
+2	K041156	Avant Digital Pulse Oximetry System, Models 4000, 4001	Nonin Medical, Inc.	2004	1
+3	K043359	4100 Patient Oximeter Module	Nonin Medical, Inc.	2005	—
+2	K031487	Model Avant 2120 Pulse Oximeter and Nibp	Nonin Medical, Inc.	2004	—
+4	K081285	Finger Pulse Oximeter, Model 9560	Nonin Medical, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	5	0
2005	4	0
2006	3	0
2007	3	0
2008	5	0
2009	6	0
2010	4	0
2011	9	0
2012	11	0
2013	12	0
2014	7	0
2015	5	0
2016	8	0
2017	8	0
2018	7	0
2019	10	0
2020	10	0
2021	2	0
2022	12	0
2023	6	0
2024	11	0
2025	16	0
2026	5	0

FIG. 1 — Lineage of K970763, 1997–2026Source: 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 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? (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
*	—	MDE ESCORT® II+ 400 Series Monitor Named without a submission number			—
*	—	MDE ESCORT® II Series 300 Monitor Named without a submission number			—

What descends from it? (171)

See all 171

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

Number	Device	Applicant	Decided	Descendants
K013319	Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor	Nonin Medical, Inc.	2002	124
K022274	Carecompanion Patient Station & Nurse Station	Neptec Design Group, Ltd.	2003	39
K051907	Innocor	Innovision A/S	2006	4
K043354	Modular Telemetry System for the Vision Telepak, Model 20701	Invivo Research, Inc.	2005	0

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, K013319 (Nonin Medical, Inc., 2002) has gone furthest, with 124 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	—

What is it indicated for?

The MTS Option for the ESCORT II Monitor is a portable monitor intended to be used for monitoring vital signs (ECG & SpO2) of critically ill adult and pediatric patients in the hospital 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/K970763 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970763: Modular Telemetry System (MTS) Option for the Mde Escort II Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970763

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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