510(k) · Cleared
ClearedMobilecare Monitor, Model 2100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aframe Digital, Inc. · KMI Monitor, Bed Patient
Cleared on Apr 24, 2009 as substantially equivalent to K925529 (Care Electronics, Inc., 1993) after a 93-day review. Its family tree reaches back 1 generation to 1993. 14 later devices descend from it.
- Decided
- Apr 24, 2009
- Review
- 93 days
- Class
- Class I
- Product code
- KMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925529 (1993). 14 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK925529 Wander CareCare Electronics, Inc. · 1993
- This deviceK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK101109 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 · 2 generations on · 3 of its ownK103536 Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K101109VivatrakWireless Medcare, LLC · 2010 · cites it directly12descendants
- 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 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925529 | Wander Care | Care Electronics, Inc. | 1993 | — |
| 0 (this device) | K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | 2009 | — |
| +1 | 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 | — |
| +2 | K103536 | Ibed Wireless with Ibed Awareness | Stryker Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K925529 | Wander CareSummary page 3…Inc. myPHD T M ) TABS Professional WanderCare monitors w/Wireless (K925529) TABS System (Reg. 1929691) Attribute Indications for use TABS Sy… | 1993 |
| * | — | Stanley Security Solutions, Inc., Senior Technologies Div. TABS Elite and Wireless TABs… Named without a submission number |
What descends from it? (14)
See all 144 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?
- Its one ancestor has no recall.
- Of its descendants, K101109 (Wireless Medcare, LLC, 2010) has gone furthest, with 12 descendants of its own.
How does its category compare?
All KMI devicesKMI Monitor, Bed Patient: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MobileCareTM Monitor 2100 system includes a MyPHD TM personal help device that is intended to monitor residents in home and long-term care facilities including independent living, assisted living and rehabilitation settings. The monitor can be placed on the wrist using the Velcro strap and used like a watch by the resident. The other form of MyPHD offered has no wrist straps so it can be clipped to the waist or used in a bandage for attachment at…
Read the full statement (200 words)
The MobileCareTM Monitor 2100 system includes a MyPHD TM personal help device that is intended to monitor residents in home and long-term care facilities including independent living, assisted living and rehabilitation settings. The monitor can be placed on the wrist using the Velcro strap and used like a watch by the resident. The other form of MyPHD offered has no wrist straps so it can be clipped to the waist or used in a bandage for attachment at other locations on the person as may be appropriate or preferred by the user or healthcare provider. The system provides an alert to designated caregivers or professional staff automatically at pre-set thresholds to indicate an impact has occurred. The system also includes an emergency (panic) button that can be pressed by the monitored individual to alert caregivers as needed. The users of the system include staff and residents. The product is intended to be used on a 24-hour basis. The system is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090138: Mobilecare Monitor, Model 2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090138
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