510(k) Report

510(k) · Cleared

Cleared

Lifebed Network Patient Vigilance System

K100745510(k) SpecialCleared Apr 15, 201030-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hoana Medical, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Apr 15, 2010 as substantially equivalent to K052446 (Hoana Medical, Inc., 2006) and 4 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1992.

Decided
Apr 15, 2010
Review
30 days
Class
Class II
Product code
DRT
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K915436 (1992). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestorK915436 · Bladderscan Bvi 2500 · Diagnostic Ultrasound Corp. · 1992K955840 · Bladdermanager Pci 5000 / Bladderscan Bvi 5000 · Diagnostic Ultrasound Corp. · 1996K022153 · Bladderscan Bvi 6100 · Diagnostic Ultrasound Corp. · 2002 · recalledK030763 · Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System · Diagnostic Ultrasound Corp. · 2003 · recalledK083534 · Lifebed Network Patient Vigilance System · Hoana Medical, Inc. · 200919901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor K083534 · Lifebed Network Patient Vigilance System · Hoana Medical, Inc. · 2009K030763 · Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System · Diagnostic Ultrasound Corp. · 2003 · recalledK022153 · Bladderscan Bvi 6100 · Diagnostic Ultrasound Corp. · 2002 · recalledK955840 · Bladdermanager Pci 5000 / Bladderscan Bvi 5000 · Diagnostic Ultrasound Corp. · 1996K915436 · Bladderscan Bvi 2500 · Diagnostic Ultrasound Corp. · 1992−50
  1. Root · 5 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
  2. 4 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
  3. 3 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
  4. 2 generations backK030763 Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemDiagnostic Ultrasound Corp. · 2003 · Recalled
  5. 1 generation backK083534 Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009
  6. This deviceK100745 Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K915436Bladderscan Bvi 2500Diagnostic Ultrasound Corp.1992—
−4K955840Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp.1996—
−3K022153Bladderscan Bvi 6100Diagnostic Ultrasound Corp.20021
−2K030763Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemDiagnostic Ultrasound Corp.20031
−1K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc.2009—
0 (this device)K100745Lifebed Network Patient Vigilance SystemHoana Medical, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200610
200710
200810
FIG. 1 — Lineage of K100745, 1992–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K052446LG1 Intelligent Medical Vigilance System
Summary page 1
…Name Monitor, Cardiac 74DIRT, 870.2300 Substantially Equivalent Devices LG1 Patient Vigilance System (K(052446) LifeBed Patient Vigilance System (K(082366)…
Hoana Medical, Inc.2006—
*K082366Lifebed Patient Vigilance System
Summary page 2
…omponent of the Lifelled Network; this submission relies upon the testing done for the LIi Patient Vigilance System (K(052446), LifeBed Patient Vigilance System (K082366), and the UifeBed Network Patient Vigilance System (K(083534) Biocompatibility Testing No changes were made to patient…
Hoana Medical, Inc.2008—
*K083534Lifebed Network Patient Vigilance System
Summary page 1
…LifeBed Patient Vigilance System (K(082366) LifeBed Network Patient Vigilance System (1(083534) Verathon, Corp BVI 9400 with ScanPoint (KO071217)…
Hoana Medical, Inc.2009—
*K071217Bladderscan Bvi 9400 Ultrasound
Summary page 1
…LifeBed Network Patient Vigilance System (1(083534) Verathon, Corp BVI 9400 with ScanPoint (KO071217) Diagnostic Ultrasound BVM6500 with ScanPoint (1(030763) Description of the Lifeaed…
Verathon Incorporated20071
*K030763Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System
Summary page 1
…Verathon, Corp BVI 9400 with ScanPoint (KO071217) Diagnostic Ultrasound BVM6500 with ScanPoint (1(030763) Description of the Lifeaed Network Patient Vigilance System This submission isan update to the LifeBed Network Patient Vigilan…
Diagnostic Ultrasound Corp.20031

Also cleared against K052446: 3 other devices →

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 18 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
  • 3 of the 11 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K052446.

How does its category compare?

All DRT devices

DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DRT

1in 2025

2007: 12008: 12009: 62010: 32011: 32012: 12013: 12015: 12016: 12017: 12018: 12019: 12021: 22022: 12023: 12024: 32025: 12026 (partial year): 5
2007high 6 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRT

228in 2024

2009: 70 days median2010: 44 days median2011: 149 days median2024: 228 days median2026 (partial year): 120 days median
2007high 228 (2024) · low 44 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRT

1in 2024

2011: 12021: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRT

40in 2025

2007: 1132008: 992009: 1182010: 632011: 362012: 472013: 162014: 262015: 482016: 552017: 1592018: 2242019: 4472020: 502021: 852022: 352023: 472024: 292025: 40
2007high 447 (2019) · low 16 (2013)2025

MAUDE reports naming product code DRT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0113
20081—099
20096700118
2010344063
20113149136
20121—047
20131—016
20140—026
20151—048
20161—055
20171—0159
20181—0224
20191—0447
20200—050
20212—185
20221—035
20231—047
20243228129
20251—040
202651200—

What is it indicated for?

The LifeBed Network Patient Vigilance System is intended for use with adult patients by health care professionals in the continuous measurement of heart rate, respiratory rate, and as an integral part of fall prevention protocols.

Indications for use as stated in the FDA summary.

Also cleared against K052446

3 other devices cite the same predicate.

  • K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009
  • K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
  • K082366Lifebed Patient Vigilance SystemHoana Medical, Inc. · 2008

More from Hoana Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • K092037Lifegurney Network Patient Vigilance SystemHoana Medical, Inc. · 2009
  • K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009
  • K082366Lifebed Patient Vigilance SystemHoana Medical, Inc. · 2008
  • K052446LG1 Intelligent Medical Vigilance SystemHoana Medical, Inc. · 2006

Recent decisions in DRT

The DRT category page

  • K262447The Circadia CX00 System (CX00)Circadia Health, Inc. · 2026
  • K254058DistaSense (TM) (v1)Life Detection Technologies · 2026
  • K261286The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K252676The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K253388Sleepiz One+ (Model 2.5)Sleepiz AG · 2026

https://510kreport.com/device/K100745 · printed Nov 3, 2026

Cite this page

510(k) Report. “K100745: Lifebed Network Patient Vigilance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100745

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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