510(k) · Cleared
ClearedLeaf Patient Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leaf Healthcare, Inc. · KMI Monitor, Bed Patient
Cleared on Nov 10, 2014 as substantially equivalent to K130752 (Centauri Medical, Inc., 2013) after a 122-day review. Its family tree reaches back 4 generations to 1993. 5 later devices descend from it.
- Decided
- Nov 10, 2014
- Review
- 122 days
- Class
- Class I
- Product code
- KMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925529 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK925529 Wander CareCare Electronics, Inc. · 1993
- 3 generations backK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
- 2 generations backK101109 VivatrakWireless Medcare, LLC · 2010
- 1 generation backK130752 Dynasense SystemCentauri Medical, Inc. · 2013
- This deviceK141877 Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK191882 Masimo Centroid SystemMasimo Corporation · 2020
- Descendant · 2 generations on · 1 of its ownK223498 Radius VSM and AccessoriesMasimo Corporation · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK253417 Masimo Root Monitoring SystemMasimo Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK250757 Radius VSM and AccessoriesMasimo Corporation · 2025
- Descendant · cites it directly · 0 of its ownK233096 PRESSUREALERT® Pressure Monitoring SystemPosition Health, LLC · 2024
Most influential descendants
Showing 5 of 5 · See all- K191882Masimo Centroid SystemMasimo Corporation · 2020 · cites it directly3descendants
- K223498Radius VSM and AccessoriesMasimo Corporation · 2023 · 2 generations on1descendant
- K253417Masimo Root Monitoring SystemMasimo Corporation · 2026 · 2 generations on0descendants
- K250757Radius VSM and AccessoriesMasimo Corporation · 2025 · 3 generations on0descendants
- K233096PRESSUREALERT® Pressure Monitoring SystemPosition Health, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925529 | Wander Care | Care Electronics, Inc. | 1993 | — |
| −3 | K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | 2009 | — |
| −2 | K101109 | Vivatrak | Wireless Medcare, LLC | 2010 | — |
| −1 | K130752 | Dynasense System | Centauri Medical, Inc. | 2013 | — |
| 0 (this device) | K141877 | Leaf Patient Monitoring System | Leaf Healthcare, Inc. | 2014 | — |
| +1 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | — |
| +2 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 2 |
| +2 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | — |
| +3 | K250757 | Radius VSM and Accessories | Masimo Corporation | 2025 | — |
| +1 | K233096 | PRESSUREALERT® Pressure Monitoring System | Position Health, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (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 |
|---|---|---|---|
| * | K130752 | Dynasense SystemSummary page 4…itor Classification: 21 CFR§880.2400, Bed-patient monitor, Class I Product Code: KMI, Monitor, Bed Patient PREDICATE DEVICE e Centauri Medical, Inc. DynaSense System (K130752) 510(k) SUMMARY INDICATIONS FOR USE The Leaf Patient Monitoring System monitors the orientation and activity of… | 2013 |
What descends from it? (5)
2 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 21 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191882 (Masimo Corporation, 2020) has gone furthest, with 3 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. 2014, 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 Leaf Patient Monitoring System monitors the orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. The Leaf Patient Monitoring System provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing and long-term care facilities, including independent living, assisted-living and rehabilitation facilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141877: Leaf Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141877
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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