510(k) · Cleared
ClearedVitelcare Turtle, Model 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visual Telecommunications Network, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 1, 2005 as substantially equivalent to K040581 (Vitel Net, 2004) after a 55-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Feb 1, 2005
- Review
- 55 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000557 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000557 Medvizer Pacs, Model Release 2000Vitel Net · 2000
- 1 generation backK040581 Medvizertm Vitelcare Patient Monitoring SystemVitel Net · 2004
- This deviceK043368 Vitelcare Turtle, Model 400Visual Telecommunications Network, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK060712 Vitelcare C-Turtle Patient Monitoring SystemVisual Telecommunications Network, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000557 | Medvizer Pacs, Model Release 2000 | Vitel Net | 2000 | — |
| −1 | K040581 | Medvizertm Vitelcare Patient Monitoring System | Vitel Net | 2004 | — |
| 0 (this device) | K043368 | Vitelcare Turtle, Model 400 | Visual Telecommunications Network, Inc. | 2005 | — |
| +1 | K060712 | Vitelcare C-Turtle Patient Monitoring System | Visual Telecommunications Network, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K040581 | Medvizertm Vitelcare Patient Monitoring SystemSummary page 1…g System Common Name: Turtle 400 Patient Monitoring System Classification: Not Classified Predictive Device: ViTelCare TM Patient Monitoring System (K040581) Manufactured By: ViTel Net 221 Elizabeth Street Utica, NY 13501 Description o… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060712 | Vitelcare C-Turtle Patient Monitoring System | 2006 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060712 (Visual Telecommunications Network, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040581.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
ViTelCareTM Turtle 400 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 MedVizerTM ViTelCare Call Center where a qualified healthcare practitioner can review the…
Read the full statement (98 words)
ViTelCareTM Turtle 400 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 MedVizerTM ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. 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.
https://510kreport.com/device/K043368 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043368: Vitelcare Turtle, Model 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043368
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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