510(k) · Cleared
ClearedZymed Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies · DSI Detector And Alarm, Arrhythmia
Cleared on Oct 7, 1998 as substantially equivalent to K951370 (Zymed Medical Instrumentation, 1995) and 1 other predicate after a 260-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Oct 7, 1998
- Review
- 260 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930806 (1994). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- This deviceK980186 Zymed Telemetry SystemAgilent Technologies · 1998
- Descendant · cites it directly · 1 of its ownK984089 Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation · 1999
- Descendant · 2 generations on · 0 of its ownK003763 2010 Plus Holter for WindowsAgilent Technologies · 2001
- Descendant · cites it directly · 0 of its ownK990093 Zymed Telemetry System: Model EasiviewAgilent Technologies · 1999
Most influential descendants
Showing 3 of 3 · See all- K984089Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation · 1999 · cites it directly1descendant
- K0037632010 Plus Holter for WindowsAgilent Technologies · 2001 · 2 generations on0descendants
- K990093Zymed Telemetry System: Model EasiviewAgilent Technologies · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| 0 (this device) | K980186 | Zymed Telemetry System | Agilent Technologies | 1998 | — |
| +1 | K984089 | Zymed Telemetry System, Model Easi View | Zymed Medical Instrumentation | 1999 | — |
| +2 | K003763 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| +1 | K990093 | Zymed Telemetry System: Model Easiview | Agilent Technologies | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K951370 | Zymed Telemetry System; Model T8010Summary page 1…sification Name: Detection and Alarm, Arthythmia (per 21 CFR 870.1025) Legally markered device to whuch S.E. is claimed. Zymed Telemetry System: Model EasiView — 510(k) K 951370 Zymed Holier Scanning System: Model 2010 — 510¢k) K 930806 Description: A Zymed Telemenry monitoring system consists af a series… | 1995 |
| * | K930806 | Zymed Holter Scanner Model 2010Summary page 1…R 870.1025) Legally markered device to whuch S.E. is claimed. Zymed Telemetry System: Model EasiView — 510(k) K 951370 Zymed Holier Scanning System: Model 2010 — 510¢k) K 930806 Description: A Zymed Telemenry monitoring system consists af a series of mierface devices 1o mclude FCG wansmifters, a central T… | 1994 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Assessment of symptoms that may be related to rhythm disturbances of the heart: Patients with palpitations; The evaluation of arrhythmia’s in patients from pediatric to adult age.
Assessment of risk in patients with or without symptoms of arrhythmia.
Assessment of efficacy of Antiarrhythmic therapy.
Assessment of Pacemaker Function.
Assessment of real time ST segment analysis.
Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing.
Assessment is indicated for single-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/K980186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980186: Zymed Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980186
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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