510(k) · Cleared
ClearedNexsystem Ambulatory Patient Monitor Model Nex 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexan Telemed, Ltd. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Dec 28, 1999 as substantially equivalent to K980619 (Sabratek Corp., 1998) and 5 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Dec 28, 1999
- Review
- 61 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K864318 (1987). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 2 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 1 generation backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- This deviceK993643 Nexsystem Ambulatory Patient Monitor Model Nex 100Nexan Telemed, Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −2 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −1 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| 0 (this device) | K993643 | Nexsystem Ambulatory Patient Monitor Model Nex 100 | Nexan Telemed, Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 4 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K980619 | Sabratek Patient Home Management SystemSummary page 1…le Reynolds Tracker Holter Recorder Reynolds Pathfinder 7000 Holter Analyser Instromedix Poseidon Cardiac Monitoring System 870.2340 868.2375 880.2910 870.2910 510(k) K980619 K951246 K974149 K943278 K951902 K964408 Page 117 of 125 Nexan Telemed Ltd. 510(k) Submission 14.4 Device Descri… | 1998 |
| * | K951246 | Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsSummary page 1…lds Tracker Holter Recorder Reynolds Pathfinder 7000 Holter Analyser Instromedix Poseidon Cardiac Monitoring System 870.2340 868.2375 880.2910 870.2910 510(k) K980619 K951246 K974149 K943278 K951902 K964408 Page 117 of 125 Nexan Telemed Ltd. 510(k) Submission 14.4 Device Description 1… | 1996 |
| * | K974149 | Ambulatory X-12 Telemetry ModuleSummary page 1…ker Holter Recorder Reynolds Pathfinder 7000 Holter Analyser Instromedix Poseidon Cardiac Monitoring System 870.2340 868.2375 880.2910 870.2910 510(k) K980619 K951246 K974149 K943278 K951902 K964408 Page 117 of 125 Nexan Telemed Ltd. 510(k) Submission 14.4 Device Description 14.4.1 Sy… | 1998 |
| * | K943278 | Tracker 2/Tracker 3 Holter RecorderSummary page 1…er Recorder Reynolds Pathfinder 7000 Holter Analyser Instromedix Poseidon Cardiac Monitoring System 870.2340 868.2375 880.2910 870.2910 510(k) K980619 K951246 K974149 K943278 K951902 K964408 Page 117 of 125 Nexan Telemed Ltd. 510(k) Submission 14.4 Device Description 14.4.1 System Ove… | 1994 |
| * | K951902 | Pathfinder 700 Holter AnalyzerSummary page 1…der Reynolds Pathfinder 7000 Holter Analyser Instromedix Poseidon Cardiac Monitoring System 870.2340 868.2375 880.2910 870.2910 510(k) K980619 K951246 K974149 K943278 K951902 K964408 Page 117 of 125 Nexan Telemed Ltd. 510(k) Submission 14.4 Device Description 14.4.1 System Overview T… | 1996 |
| * | K964408 | Poseidon Cardiac Monitoring System (PCMS)Summary page 1…olds Pathfinder 7000 Holter Analyser Instromedix Poseidon Cardiac Monitoring System 870.2340 868.2375 880.2910 870.2910 510(k) K980619 K951246 K974149 K943278 K951902 K964408 Page 117 of 125 Nexan Telemed Ltd. 510(k) Submission 14.4 Device Description 14.4.1 System Overview The Nexys… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 19 ancestors have a recall of any class.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The Nexsystem ambulatory patient monitoring system is intended for use in the home or alternate care settings. It consists of a patient-worn sensor (Nexisensor), signal transfer unit (Nexender), communications module (Nextation), and a telemonitoring station computer based display and storage system (TMS) located at the health care professional’s facility. The device stores and transmits ECG data, respiratory data, skin temperature, systolic and diastolic blood pressure (Non-invasive), and PEF and FEV1.
The Nexsystem is not for use as a critical care monitoring system.
The Nexsystem is not an apnea monitor.
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/K993643 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993643: Nexsystem Ambulatory Patient Monitor Model Nex 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993643
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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