510(k) · Cleared
ClearedDynasense System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centauri Medical, Inc. · KMI Monitor, Bed Patient
Cleared on Aug 15, 2013 as substantially equivalent to K101109 (Wireless Medcare, LLC, 2010) and 1 other predicate after a 149-day review. Its family tree reaches back 3 generations to 1993. 6 later devices descend from it.
- Decided
- Aug 15, 2013
- Review
- 149 days
- Class
- Class I
- Product code
- KMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925529 (1993). 6 later devices descend from it, 1 citing it directly.
- 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 deviceK130752 Dynasense SystemCentauri Medical, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK141877 Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK191882 Masimo Centroid SystemMasimo Corporation · 2020
- Descendant · 3 generations on · 1 of its ownK223498 Radius VSM and AccessoriesMasimo Corporation · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK253417 Masimo Root Monitoring SystemMasimo Corporation · 2026
- Descendant · 4 generations on · 0 of its ownK250757 Radius VSM and AccessoriesMasimo Corporation · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141877Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014 · cites it directly5descendants
- K191882Masimo Centroid SystemMasimo Corporation · 2020 · 2 generations on3descendants
- K223498Radius VSM and AccessoriesMasimo Corporation · 2023 · 3 generations on1descendant
- K253417Masimo Root Monitoring SystemMasimo Corporation · 2026 · 3 generations on0descendants
- K250757Radius VSM and AccessoriesMasimo Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925529 | Wander Care | Care Electronics, Inc. | 1993 | — |
| −2 | K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | 2009 | — |
| −1 | K101109 | Vivatrak | Wireless Medcare, LLC | 2010 | — |
| 0 (this device) | K130752 | Dynasense System | Centauri Medical, Inc. | 2013 | — |
| +1 | K141877 | Leaf Patient Monitoring System | Leaf Healthcare, Inc. | 2014 | — |
| +2 | K191882 | Masimo Centroid System | Masimo Corporation | 2020 | — |
| +3 | K223498 | Radius VSM and Accessories | Masimo Corporation | 2023 | 2 |
| +3 | K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026 | — |
| +4 | K250757 | Radius VSM and Accessories | Masimo Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K101109 | VivatrakSummary page 1…ssification: 21 CFR§880.2400, Bed-patient monitor, Class I Product Code: KMI, Monitor, Bed Patient PREDICATE DEVICE(S) * Wireless MedCARE VivaTRAK h System (K 101 109) * AFrame Digital MobileCare Monitor m (K090138) Section 5 510(k) Summary (CONT.) INDICATIONS FOR USE DynaSen… | 2010 |
| * | K090138 | Mobilecare Monitor, Model 2100Summary page 1…Class I Product Code: KMI, Monitor, Bed Patient PREDICATE DEVICE(S) * Wireless MedCARE VivaTRAK h System (K 101 109) * AFrame Digital MobileCare Monitor m (K090138) Section 5 510(k) Summary (CONT.) INDICATIONS FOR USE DynaSense monitors orientation and activity of patients su… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141877 | Leaf Patient Monitoring System | 2014 | 5 |
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 3.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K141877 (Leaf Healthcare, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K101109.
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?
DynaSense monitors orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. DynaSense 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 as stated in the FDA summary.
https://510kreport.com/device/K130752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130752: Dynasense System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130752
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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