510(k) Report

510(k) · Cleared

Cleared

Medvizertm Vitelcare Patient Monitoring System

K040581510(k) TraditionalCleared May 27, 200484-day reviewClass II21 CFR 870.2700

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

Vitel Net · DQA Oximeter

Cleared on May 27, 2004 as substantially equivalent to K000557 (Vitel Net, 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.

Decided
May 27, 2004
Review
84 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000557 (2000). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2005: 1 descendant clearedK000557 · Medvizer Pacs, Model Release 2000 · Vitel Net · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants K000557 · Medvizer Pacs, Model Release 2000 · Vitel Net · 20000
  1. Root · 1 generation backK000557 Medvizer Pacs, Model Release 2000Vitel Net · 2000
  2. This deviceK040581 Medvizertm Vitelcare Patient Monitoring SystemVitel Net · 2004
  3. Descendant · cites it directly · 1 of its ownK043368 Vitelcare Turtle, Model 400Visual Telecommunications Network, Inc. · 2005
  4. Descendant · cites it directly · 0 of its ownK060712 Vitelcare C-Turtle Patient Monitoring SystemVisual Telecommunications Network, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K043368Vitelcare Turtle, Model 400Visual Telecommunications Network, Inc. · 2005 · cites it directly1descendant
  • K060712Vitelcare C-Turtle Patient Monitoring SystemVisual Telecommunications Network, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000557Medvizer Pacs, Model Release 2000Vitel Net2000—
0 (this device)K040581Medvizertm Vitelcare Patient Monitoring SystemVitel Net2004—
+1K043368Vitelcare Turtle, Model 400Visual Telecommunications Network, Inc.2005—
+1K060712Vitelcare C-Turtle Patient Monitoring SystemVisual Telecommunications Network, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
FIG. 1 — Lineage of K040581, 2000–2006Source: 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 DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K000557Medvizer Pacs, Model Release 2000
Summary page 1
…e Trade Name: MedVizerTM ViTelCare Patient Monitoring System Common Name: patient monitoring system Classification: Not classified Predicate Device: MedVizer TM PACS (K000557) Manufactured by: ViTel Net 8201 Greensboro Drive, Suite 820 McLean, VA 22102 Descri…
Vitel Net2000—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043368Vitelcare Turtle, Model 400Visual Telecommunications Network, Inc.20051
K060712Vitelcare C-Turtle Patient Monitoring SystemVisual Telecommunications Network, Inc.20060

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?

  • Its one ancestor has no recall.
  • Of its descendants, K043368 (Visual Telecommunications Network, Inc., 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

MedVizerTM ViTelCare Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizerrM ViTelCare Call Center where a qualified healthcare practitioner can review the…

Read the full statement (111 words)

MedVizerTM ViTelCare Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizerrM ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference connection when desired. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.

Indications for use as stated in the FDA summary.

More from Vitel Net

2 FDA decisions under this applicant name. See the company

  • K000557Medvizer Pacs, Model Release 2000Vitel Net · 2000

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https://510kreport.com/device/K040581 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040581: Medvizertm Vitelcare Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040581

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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