510(k) · Cleared
ClearedLifebed Patient Vigilance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoana Medical, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Sep 26, 2008 as substantially equivalent to K052446 (Hoana Medical, Inc., 2006) after a 39-day review. Its family tree reaches back 2 generations to 1999. 3 later devices descend from it.
- Decided
- Sep 26, 2008
- Review
- 39 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992413 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK992413 Escort 100/300 Series B (Escort II) Patient MonitorMedical Data Electronics · 1999
- 1 generation backK052446 LG1 Intelligent Medical Vigilance SystemHoana Medical, Inc. · 2006
- This deviceK082366 Lifebed Patient Vigilance SystemHoana Medical, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK083534 Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK100745 Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK092037 Lifegurney Network Patient Vigilance SystemHoana Medical, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009 · cites it directly2descendants
- K100745Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2010 · cites it directly0descendants
- K092037Lifegurney Network Patient Vigilance SystemHoana Medical, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992413 | Escort 100/300 Series B (Escort II) Patient Monitor | Medical Data Electronics | 1999 | — |
| −1 | K052446 | LG1 Intelligent Medical Vigilance System | Hoana Medical, Inc. | 2006 | — |
| 0 (this device) | K082366 | Lifebed Patient Vigilance System | Hoana Medical, Inc. | 2008 | — |
| +1 | K083534 | Lifebed Network Patient Vigilance System | Hoana Medical, Inc. | 2009 | — |
| +1 | K100745 | Lifebed Network Patient Vigilance System | Hoana Medical, Inc. | 2010 | — |
| +2 | K092037 | Lifegurney Network Patient Vigilance System | Hoana Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 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 DRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K052446 | LG1 Intelligent Medical Vigilance SystemSummary page 1…74DRT, 870.2300 Substantially Equivalent Devices: LGI Intelligent Medical Vigilance System (K052446) Description of the LifeBed Patient Vigilance System: The LifeBed Patient Vigilance System consists of two (2) main components:… | 2006 |
What descends from it? (3)
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 9 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083534 (Hoana Medical, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K052446.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The LifeBed Patient Vigilance System is intended to measure heart rate and
respiratory rate in adult patients, in bed, in a general care hospital environment.
The system will also monitor bed exit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082366: Lifebed Patient Vigilance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082366
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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