510(k) · Cleared
ClearedPRESSUREALERT® Pressure Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Position Health, LLC · SBO Bed-Patient Activity Monitoring System
Cleared on Jun 21, 2024 as substantially equivalent to K141877 (Leaf Healthcare, Inc., 2014) after a 269-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jun 21, 2024
- Review
- 269 days
- Class
- Class I
- Product code
- SBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K925529 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK925529 Wander CareCare Electronics, Inc. · 1993
- 4 generations backK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
- 3 generations backK101109 VivatrakWireless Medcare, LLC · 2010
- 2 generations backK130752 Dynasense SystemCentauri Medical, Inc. · 2013
- 1 generation backK141877 Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014
- This deviceK233096 PRESSUREALERT® Pressure Monitoring SystemPosition Health, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925529 | Wander Care | Care Electronics, Inc. | 1993 | — |
| −4 | K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | 2009 | — |
| −3 | K101109 | Vivatrak | Wireless Medcare, LLC | 2010 | — |
| −2 | K130752 | Dynasense System | Centauri Medical, Inc. | 2013 | — |
| −1 | K141877 | Leaf Patient Monitoring System | Leaf Healthcare, Inc. | 2014 | — |
| 0 (this device) | K233096 | PRESSUREALERT® Pressure Monitoring System | Position Health, LLC | 2024 | — |
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 SBO? 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 |
|---|---|---|---|
| * | K141877 | Leaf Patient Monitoring SystemSummary page 5…cate Device Manufacturer Trade Name 510(k) Number Product Code Primary Leaf Healthcare Leaf Patient K141877 KMI Predicate Incorporated Monitoring System 5. Product De… | 2014 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K141877.
How does its category compare?
All SBO devicesSBO Bed-Patient Activity Monitoring System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SBO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SBO
Too few SBO 510(k)s in any year since 2007 to give a median.
Recalls per year · SBO
No recall names SBO since 2007.
Adverse event reports per year · SBO
No MAUDE report names SBO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PRESSUREALERT® Pressure Monitoring System monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to execute an individualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the 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/K233096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233096: PRESSUREALERT® Pressure Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233096
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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