510(k) · Cleared
ClearedNetguard Automated Clinician Alert System, Model 0998-00-1600-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · DSI Detector And Alarm, Arrhythmia
Cleared on Sep 25, 2007 as substantially equivalent to K021681 (Welch Allyn Protocol, Inc., 2002) and 1 other predicate after an 85-day review. Its family tree reaches back 4 generations to 1993. 5 later devices descend from it.
- Decided
- Sep 25, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K925411 (1993). 8 ancestors in all, the oldest K913193 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK925411 Model 2041-PC/ST Cardiac Telemetry MonitorAccucore, Inc. · 1993
- 3 generations backK972121 Acuity Central StationProtocol Systems, Inc. · 1997
- 2 generations backK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- 1 generation backK052160 Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 2005 · Recalled
- This deviceK071805 Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDatascope Corp. · 2007
- Descendant · cites it directly · 4 of its ownK110015 Vitalsens, Aingeal, V-PodIntelesens Limited · 2011
- Descendant · 2 generations on · 1 of its ownK132407 Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK153275 Aingeal Activity SystemIntelesens, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK151835 Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK151027 zensor systemIntelesens Limited · 2015
Most influential descendants
Showing 5 of 5 · See all- K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 2011 · cites it directly4descendants
- K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd. · 2014 · 2 generations on1descendant
- K153275Aingeal Activity SystemIntelesens, Ltd. · 2016 · 2 generations on0descendants
- K151835Vital Signs Patch SystemLifewatch Technologies, Ltd. · 2016 · 3 generations on0descendants
- K151027zensor systemIntelesens Limited · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925411 | Model 2041-PC/ST Cardiac Telemetry Monitor | Accucore, Inc. | 1993 | — |
| −3 | K972121 | Acuity Central Station | Protocol Systems, Inc. | 1997 | — |
| −2 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| −1 | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) | Welch Allyn, Inc. | 2005 | 2 |
| 0 (this device) | K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XX | Datascope Corp. | 2007 | — |
| +1 | K110015 | Vitalsens, Aingeal, V-Pod | Intelesens Limited | 2011 | — |
| +2 | K132407 | Vital Signs Patch System (in Short VSP) | Lifewatch Technologies, Ltd. | 2014 | — |
| +2 | K153275 | Aingeal Activity System | Intelesens, Ltd. | 2016 | — |
| +3 | K151835 | Vital Signs Patch System | Lifewatch Technologies, Ltd. | 2016 | — |
| +2 | K151027 | zensor system | Intelesens Limited | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 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? (2)
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 |
|---|---|---|---|
| * | K021681 | Micropaq, Models 402, 404Summary page 1…21 CFR 870.1025, Product code: DSI, Class: II Predicate Devices: MicropaqTM Vital Signs Monitor, Welch Allyn, K021681 Acuity® Central Monitoring Station, Welch Allyn, K052160 Device description:… | 2002 |
| * | K052160 | Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Summary page 1…MicropaqTM Vital Signs Monitor, Welch Allyn, K021681 Acuity® Central Monitoring Station, Welch Allyn, K052160 Device description: The NetGuard Automated Clinician Alert System is an ambulatory… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110015 | Vitalsens, Aingeal, V-Pod | 2011 | 4 |
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 14 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K110015 (Intelesens Limited, 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K021681.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 NetGuard Automated Clinician Alert System is intended for use by licensed clinicians, within a health care facility, to provide notification of life threatening cardiac events in ambulatory adult patients including:
Asystole
Ventricular-Fibrillation
NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected. The NetGuard system also provides notification for high and low heart rates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071805 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071805: Netguard Automated Clinician Alert System, Model 0998-00-1600-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071805
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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