510(k) · Cleared
Recalled · Class II · 2019Apexpro Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · DSI Detector And Alarm, Arrhythmia
Cleared on May 18, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- May 18, 2000
- Review
- 69 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 2
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK000779 Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2000
- Descendant · cites it directly · 4 of its ownK021325 Modification of Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- Descendant · cites it directly · 3 of its ownK081800 T12S Telemetry TransmitterMortara Instrument, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 3 of its ownK032369 Modification to: Apexpro Telemetry SystemGe Medical Systems Information Technologies · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK141020 Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK033365 Apexpro FH Telemetry SystemGe Medical Systems Information Technologies · 2003 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K021325Modification of Apexpro Telemetry SystemGeneral Electric Medical Systems Information Techn · 2002 · cites it directly4descendants
- K081800T12S Telemetry TransmitterMortara Instrument, Inc. · 2008 · cites it directly3descendants
- K032369Modification to: Apexpro Telemetry SystemGe Medical Systems Information Technologies · 2003 · 2 generations on3descendants
- K141020Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 2014 · 2 generations on2descendants
- K033365Apexpro FH Telemetry SystemGe Medical Systems Information Technologies · 2003 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000779 | Apexpro Telemetry System | General Electric Medical Systems Information Techn | 2000 | — |
| +1 | K021325 | Modification of Apexpro Telemetry System | General Electric Medical Systems Information Techn | 2002 | 2 |
| +1 | K081800 | T12S Telemetry Transmitter | Mortara Instrument, Inc. | 2008 | 1 |
| +2 | K032369 | Modification to: Apexpro Telemetry System | Ge Medical Systems Information Technologies | 2003 | 4 |
| +2 | K141020 | Surveyor S4 Mobile Monitor | Mortara Instrument, Inc. | 2014 | — |
| +3 | K033365 | Apexpro FH Telemetry System | Ge Medical Systems Information Technologies | 2003 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2019 | Class II | Z-0725-2020 | Software in the Use Environment | When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information… |
| Aug 30, 2019 | Class II | Z-0175-2020 | Software design | May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021325 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 4 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/K000779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000779: Apexpro Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000779
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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