510(k) · Cleared
ClearedAlarm Display Unit/Pager-Lan System (Adu)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Feb 24, 1997 after a 220-day review. The FDA summary names no predicate by number. 60 later devices descend from it.
- Decided
- Feb 24, 1997
- Review
- 220 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 2 citing it directly.
- This deviceK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- Descendant · cites it directly · 59 of its ownK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- Descendant · cites it directly · 57 of its ownK973527 Cardio-Pager SystemData Critical Corp. · 1998
- Descendant · 2 generations on · 56 of its ownK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- Descendant · 3 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- Descendant · 4 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K971868Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997 · cites it directly59descendants
- K973527Cardio-Pager SystemData Critical Corp. · 1998 · cites it directly57descendants
- K992749Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000 · 2 generations on56descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 3 generations on33descendants
- K090094Zeltiq SystemZeltiq Aesthetics · 2009 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| +1 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| +1 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| +2 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| +3 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| +4 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (60)
See all 602 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, K971868 (Marquette Electronics, Inc., 1997) has gone furthest, with 59 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 | — |
What is it indicated for?
The pager is intended for the annunciation of events to provide zone information that is secondary to the primary care provided. It provides cpecific information within 2 zone and alerts or draws an identified individual’s attention to a defined patient condition in a timely manner. Primary care via the central station, telemetry system. or patient bedside monitor remains unchanged by the addition of a pager.
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/K962827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962827: Alarm Display Unit/Pager-Lan System (Adu).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962827
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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