510(k) · Cleared
ClearedVivatrak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wireless Medcare, LLC · KMI Monitor, Bed Patient
Cleared on Jul 15, 2010 as substantially equivalent to K090138 (Aframe Digital, Inc., 2009) after an 86-day review. Its family tree reaches back 2 generations to 1993. 12 later devices descend from it.
- Decided
- Jul 15, 2010
- Review
- 86 days
- Class
- Class I
- Product code
- KMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925529 (1993). 12 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK925529 Wander CareCare Electronics, Inc. · 1993
- 1 generation backK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
- This deviceK101109 VivatrakWireless Medcare, LLC · 2010
- Descendant · cites it directly · 6 of its ownK130752 Dynasense SystemCentauri Medical, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK141877 Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK191882 Masimo Centroid SystemMasimo Corporation · 2020
- Descendant · cites it directly · 3 of its ownK103536 Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
- Descendant · 4 generations on · 1 of its ownK223498 Radius VSM and AccessoriesMasimo Corporation · 2023 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K130752Dynasense SystemCentauri Medical, Inc. · 2013 · cites it directly6descendants
- K141877Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014 · 2 generations on5descendants
- K191882Masimo Centroid SystemMasimo Corporation · 2020 · 3 generations on3descendants
- K103536Ibed Wireless with Ibed AwarenessStryker Corporation · 2010 · cites it directly3descendants
- K223498Radius VSM and AccessoriesMasimo Corporation · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925529 | Wander Care | Care Electronics, Inc. | 1993 | — |
| −1 | K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | 2009 | — |
| 0 (this device) | K101109 | Vivatrak | Wireless Medcare, LLC | 2010 | — |
| +1 | K130752 | Dynasense System | Centauri Medical, Inc. | 2013 | — |
| +2 | K141877 | Leaf Patient Monitoring System | Leaf Healthcare, Inc. | 2014 | — |
| +3 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | — |
| +1 | K103536 | Ibed Wireless with Ibed Awareness | Stryker Corporation | 2010 | — |
| +4 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 KMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K090138 | Mobilecare Monitor, Model 2100Summary page 1…f the Food, Drug and Cosmetic Act. 3. Predicate Device(s): AFramne Digital, Inc., AFrame MobileCare Monitor (K090138), Stanley Security Solutions, Inc., TABS Elite (Class 1, 5 10(k) Exempt) Stanley Healthcare Solutions, Roll… | 2009 |
| * | — | TABS Elite Named without a submission number | |
| * | — | Roll-Check Named without a submission number | |
| * | — | WellAWARE Systems Named without a submission number | |
| * | — | SafeBed Named without a submission number |
What descends from it? (12)
See all 123 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130752 (Centauri Medical, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K090138.
How does its category compare?
All KMI devicesKMI Monitor, Bed Patient: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KMI
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KMI
Too few KMI 510(k)s in any year since 2007 to give a median.
Recalls per year · KMI
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMI
83in 2025
MAUDE reports naming product code KMI, 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 | 0 | — | 1 | 20 |
| 2008 | 0 | — | 1 | 76 |
| 2009 | 1 | — | 7 | 510 |
| 2010 | 1 | — | 5 | 329 |
| 2011 | 0 | — | 2 | 379 |
| 2012 | 0 | — | 1 | 421 |
| 2013 | 2 | — | 0 | 400 |
| 2014 | 1 | — | 0 | 358 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 0 | 24 |
| 2017 | 0 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 28 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 0 | — | 0 | 69 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VivaTRAK™ System monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system provides care providers information related to patient status and care delivered. The VivaTRAK™ System is not intended…
Read the full statement (117 words)
The VivaTRAK™ System monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system provides care providers information related to patient status and care delivered.
The VivaTRAK™ System is not intended to provide automated treatment decisions or be used as a substitute for professional healthcare judgment. The VivaTRAK™ System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101109: Vivatrak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101109
Report an extraction error
Are you the manufacturer?
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