510(k) · Cleared
ClearedZymed Telemetry System, Model Easi View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zymed Medical Instrumentation · DSI Detector And Alarm, Arrhythmia
Cleared on Feb 16, 1999 as substantially equivalent to K980186 (Agilent Technologies, 1998) after a 92-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Feb 16, 1999
- Review
- 92 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930806 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 1 generation backK980186 Zymed Telemetry SystemAgilent Technologies · 1998
- This deviceK984089 Zymed Telemetry System, Model Easi ViewZymed Medical Instrumentation · 1999
- Descendant · cites it directly · 0 of its ownK003763 2010 Plus Holter for WindowsAgilent Technologies · 2001
Most influential descendants
Showing 1 of 1 · See all- K0037632010 Plus Holter for WindowsAgilent Technologies · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −1 | K980186 | Zymed Telemetry System | Agilent Technologies | 1998 | — |
| 0 (this device) | K984089 | Zymed Telemetry System, Model Easi View | Zymed Medical Instrumentation | 1999 | — |
| +1 | K003763 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K980186 | Zymed Telemetry SystemSummary page 1…ification Name: Detection and Alarm, Arrhythmia (per 21 CFR 870.1025) Legally marketed device to which S.E. is claimed. Zymed Telemetry System: Model EasiView — 510(k) K 980186 Description: A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, a centra… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K003763 | 2010 Plus Holter for Windows | 2001 | 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K003763 (Agilent Technologies, 2001) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K980186.
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 evaluations 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 Antiarthythmia therapy. Assessment of Pacemaker Function. Assessment of real time ST segment analysis. Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic…
Read the full statement (131 words)
Assessment of symptoms that may be related to rhythm disturbances of the heart; Patients with palpitations; The evaluations 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 Antiarthythmia 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 arrhythmias analysis during exercise testing.
Assessment is indicated for single-hospital environment.
Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the following parameters.
Ages: 33 to 82 years
Heights: 147 to 185 cm (58 to 73 in)
Weights: 53 to 118 kg (117 to 261 Ib)
Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/b.)
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/K984089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984089: Zymed Telemetry System, Model Easi View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984089
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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