510(k) · Cleared
ClearedIntel-GE Care Innovations Quietcare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intel-Ge Care Innovations, LLC · KMI Monitor, Bed Patient
Cleared on Oct 8, 2013 as substantially equivalent to K090138 (Aframe Digital, Inc., 2009) and 1 other predicate after a 130-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Oct 8, 2013
- Review
- 130 days
- Class
- Class I
- Product code
- KMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925529 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK925529 Wander CareCare Electronics, Inc. · 1993
- 2 generations backK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
- 1 generation backK101109 VivatrakWireless Medcare, LLC · 2010
- This deviceK131585 Intel-GE Care Innovations QuietcareIntel-Ge Care Innovations, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K090138 | Mobilecare Monitor, Model 2100Summary page 1…nt Monitor (21 CFR 880.2400, Product Code KMI, Class 1) Substantial Equivalence is claimed to the following devices: 1. MobileCareb Monitorm from AFrame Digital Inc., (K090138) 2. Wireless MedCARE LLC VIvaTRAK (K101109) Device Description Care Innovations QuietCare-Networked uses advanced motion sensors… | 2009 |
| * | K101109 | VivatrakSummary page 1…MI, Class 1) Substantial Equivalence is claimed to the following devices: 1. MobileCareb Monitorm from AFrame Digital Inc., (K090138) 2. Wireless MedCARE LLC VIvaTRAK (K101109) Device Description Care Innovations QuietCare-Networked uses advanced motion sensors to monitor Activities of Daily Living for… | 2010 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- 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. 2013, 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?
QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage. Caregivers are provided with information and notification about the occurrence of, and…
Read the full statement (167 words)
QuietCare-Networked is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. QuietCare-Networked recognizes and monitors certain patterns of activity including but not limited to bathroom and bedroom activity, residence entry/exit, and interaction with food and medication storage.
Caregivers are provided with information and notification about the occurrence of, and changes in, these monitored activity patterns and environmental conditions. Noteworthy occurrences and changes are communicated to caregivers through direct notification (pager, voice alert, email) as well as a secure Internet website.
Data from QuietCare-Networked should not be relied on as medical advice or clinical diagnosis. Caregivers should always rely on licensed medical professionals in making all health decisions and should use the information provided by QuietCare as a resource in that process.
Caregivers should not rely solely on the use of QuietCare-Networked for care management of clients/residents. Caregivers should use standard care practices established within their care organization to ensure the safety and wellness of senior clients/residents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131585: Intel-GE Care Innovations Quietcare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131585
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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