510(k) · Cleared
ClearedLifebed Network 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 Apr 13, 2009 as substantially equivalent to K052446 (Hoana Medical, Inc., 2006) and 3 other predicates after a 136-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 13, 2009
- Review
- 136 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K915436 (1992). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 3 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- 2 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- 1 generation backK030763 Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemDiagnostic Ultrasound Corp. · 2003 · Recalled
- This deviceK083534 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 · cites it directly · 0 of its ownK092037 Lifegurney Network Patient Vigilance SystemHoana Medical, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −3 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| −2 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| −1 | K030763 | Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System | Diagnostic Ultrasound Corp. | 2003 | 1 |
| 0 (this device) | K083534 | Lifebed Network Patient Vigilance System | Hoana Medical, Inc. | 2009 | — |
| +1 | K100745 | Lifebed Network Patient Vigilance System | Hoana Medical, Inc. | 2010 | — |
| +1 | K092037 | Lifegurney Network Patient Vigilance System | Hoana Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (4)
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: LGl Patient Vigilance System (K052446); LifeBed Patient Vigilance System (K0823… | 2006 |
| * | K082366 | Lifebed Patient Vigilance SystemSummary page 1…(K052446); LifeBed Patient Vigilance System (K082366) Verathon Corp. BVI 9400 with ScanPoint… | 2008 |
| * | K071217 | Bladderscan Bvi 9400 UltrasoundSummary page 4…I 9400, Diagnostic Ultrasound BVM 6500, and ScanPoint which transmits data, wirelessly, to an office or facility for later viewing, diagnosing, calibrating or archiving, K071217. Hoana Medical, Inc. 510(k) Premarket Reports… | 2007 |
| * | K030763 | Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemSummary page 1…Diagnostic Ultrasound BVM6500 with ScanPoint (K030763) Description of the Lifelled Network Patient Vigilance System: The LifeBed Network Patient Vigilance System is identical to the… | 2003 |
What descends from it? (2)
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 17 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K100745 (Hoana Medical, Inc., 2010) has gone furthest, with 0 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. 2009, 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 Network Patient Vigilance System is intended to measure heart rate, respiratory rate, and bed exit in adult patients for use by health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083534: Lifebed Network 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/K083534
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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