510(k) · Cleared

Cleared

CD Telemetry Systems

K891104510(k) TraditionalCleared Apr 19, 198948-day reviewClass II21 CFR 870.2910

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

Marquette Electronics, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Apr 19, 1989 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 125 later devices descend from it.

Decided: Apr 19, 1989
Review: 48 days
Class: Class II
Product code: DRG
Recalls: None
Predicates: 0

125 later devices descend from it, 2 citing it directly.

This deviceK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
Descendant · cites it directly · 122 of its ownK974149 Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998 · Recalled
Descendant · 2 generations on · 109 of its ownK030795 Lifesyne SystemsGmp/Companies, Inc. · 2003 · Recalled
Descendant · 3 generations on · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
Descendant · 3 generations on · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
Descendant · 4 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014

Showing 5 of 125 descendants. See all descendants

Descendants cleared per year

1998high 16 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 125 · See all

K974149Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998 · cites it directly122descendants
K030795Lifesyne SystemsGmp/Companies, Inc. · 2003 · 2 generations on109descendants
K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · 3 generations on99descendants
K113054EquivitalHidalgo Limited · 2012 · 3 generations on71descendants
K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 4 generations on70descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K891104	CD Telemetry Systems	Marquette Electronics, Inc.	1989	—
+1	K974149	Ambulatory X-12 Telemetry Module	Mortara Instrument, Inc.	1998	1
+2	K030795	Lifesyne Systems	Gmp/Companies, Inc.	2003	3
+3	K061993	Equivital, Model EQ-01	Hidalgo Limited	2006	—
+3	K113054	Equivital	Hidalgo Limited	2012	—
+4	K141167	Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software…	Vitalconnect, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2003	1	0
2004	1	0
2006	1	0
2008	3	0
2009	1	0
2010	2	0
2011	2	0
2012	3	0
2013	2	0
2014	2	0
2015	5	0
2016	4	0
2017	5	0
2018	7	0
2019	10	0
2020	9	0
2021	5	0
2022	8	0
2023	15	0
2024	12	0
2025	16	0
2026	8	0

FIG. 1 — Lineage of K891104, 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 DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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? (125)

See all 125

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

Number	Device	Applicant	Decided	Descendants
K974149	Ambulatory X-12 Telemetry Module	Mortara Instrument, Inc.	1998	122
K980299	Apex Oximeter	Marquette Medical Systems, Inc.	1998	2

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, K974149 (Mortara Instrument, Inc., 1998) has gone furthest, with 122 descendants of its own.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRG

3in 2025

2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007high 287 (2022) · low 63 (2007)2026

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

Recalls per year · DRG

3in 2007

2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DRG

52in 2025

2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, 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	6	63	3	14
2008	5	74	0	9
2009	13	94	0	5
2010	10	68	0	13
2011	9	104	0	12
2012	12	103	0	9
2013	13	146	0	13
2014	10	177	0	97
2015	2	—	0	131
2016	2	—	0	182
2017	7	98	0	484
2018	6	220	0	166
2019	5	122	0	70
2020	6	159	0	82
2021	2	—	0	107
2022	6	287	0	43
2023	4	212	0	19
2024	3	125	0	26
2025	3	127	0	52
2026	2	—	1	—

https://510kreport.com/device/K891104 · printed Nov 6, 2026

Cite this page

510(k) Report. “K891104: CD Telemetry Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891104

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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