510(k) · Cleared
ClearedZymed Model 1610
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 Dec 12, 1989 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 12, 1989
- Review
- 117 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK895208 Zymed Model 1610Agilent Technologies · 1989
- Descendant · cites it directly · 2 of its ownK962930 Spacelabs Medical Ecg Analysis SystemSpacelabs Medical, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK063490 Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 2007 · Recalled
- Descendant · cites it directly · 1 of its ownK003940 2010 Plus Holter for WindowsAgilent Technologies · 2001
- Descendant · 2 generations on · 0 of its ownK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK110779 Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K962930Spacelabs Medical Ecg Analysis SystemSpacelabs Medical, Inc. · 1997 · cites it directly2descendants
- K063490Spacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. · 2007 · 2 generations on1descendant
- K0039402010 Plus Holter for WindowsAgilent Technologies · 2001 · cites it directly1descendant
- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · 2 generations on0descendants
- K110779Spacelabs Smart Disclosure SystemSpacelabs Healthcare · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895208 | Zymed Model 1610 | Agilent Technologies | 1989 | — |
| +1 | K962930 | Spacelabs Medical Ecg Analysis System | Spacelabs Medical, Inc. | 1997 | — |
| +2 | K063490 | Spacelabs Medical Full Disclosure System, Model 91810 | Spacelabs Medical, Inc. | 2007 | 1 |
| +1 | K003940 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| +2 | K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015 | — |
| +3 | K110779 | Spacelabs Smart Disclosure System | Spacelabs Healthcare | 2011 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K962930 (Spacelabs Medical, Inc., 1997) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K895208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K895208: Zymed Model 1610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K895208
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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