510(k) · Cleared
ClearedeCareCoordinator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visicu, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 14, 2017 as substantially equivalent to K141706 (Visicu, Inc., 2014) after a 99-day review. Its family tree reaches back 6 generations to 1987. 1 later device descends from it.
- Decided
- Jul 14, 2017
- Review
- 99 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K864318 (1987). 19 ancestors in all, the oldest K790130 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 4 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 3 generations backK992478 Physiological Signal Transmitter and Receiver, Model 3810AHewlett-Packard, Healthcare Solutions Group · 1999
- 2 generations backK041674 The M3810A Philips Telemonitoring System with M3814A SPO2 UnitPhilips Medical Systems · 2004 · Recalled
- 1 generation backK141706 Ecare Coordinator (Ecc)Visicu, Inc. · 2014 · Recalled
- This deviceK171029 eCareCoordinatorVisicu, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK222398 Care Team PortalVivify Health, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222398Care Team PortalVivify Health, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −5 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −4 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −3 | K992478 | Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard, Healthcare Solutions Group | 1999 | — |
| −2 | K041674 | The M3810A Philips Telemonitoring System with M3814A SPO2 Unit | Philips Medical Systems | 2004 | 2 |
| −1 | K141706 | Ecare Coordinator (Ecc) | Visicu, Inc. | 2014 | 2 |
| 0 (this device) | K171029 | eCareCoordinator | Visicu, Inc. | 2017 | — |
| +1 | K222398 | Care Team Portal | Vivify Health, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K141706 | Ecare Coordinator (Ecc)Summary page 4…r. III. Predicate device information Trade name: eCareCoordinator Manufacturer: Visicu, Inc. 510(k) clearance: K141706 Classification name Radiofrequency physiological signal transmitter and receiver. Device class: C… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222398 | Care Team Portal | 2023 | 0 |
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 30 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K222398 (Vivify Health, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171029: eCareCoordinator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171029
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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