510(k) · Cleared
ClearedVitelcare C-Turtle Patient Monitoring System
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 Apr 19, 2006 as substantially equivalent to K040581 (Vitel Net, 2004) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 19, 2006
- Review
- 34 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000557 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK000557 Medvizer Pacs, Model Release 2000Vitel Net · 2000
- 2 generations backK040581 Medvizertm Vitelcare Patient Monitoring SystemVitel Net · 2004
- 1 generation backK043368 Vitelcare Turtle, Model 400Visual Telecommunications Network, Inc. · 2005
- This deviceK060712 Vitelcare C-Turtle Patient Monitoring SystemVisual Telecommunications Network, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000557 | Medvizer Pacs, Model Release 2000 | Vitel Net | 2000 | — |
| −2 | K040581 | Medvizertm Vitelcare Patient Monitoring System | Vitel Net | 2004 | — |
| −1 | K043368 | Vitelcare Turtle, Model 400 | Visual Telecommunications Network, Inc. | 2005 | — |
| 0 (this device) | K060712 | Vitelcare C-Turtle Patient Monitoring System | Visual Telecommunications Network, Inc. | 2006 | — |
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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040581 | Medvizertm Vitelcare Patient Monitoring SystemSummary page 1…: C-Turtle Patient Monitoring System Classification: Not Classified Predictive Device: ViTelCareTM Patient Monitoring System (K04058 1) ViTelCareTM Turtle 800 Patient Monitoring System (C040283)… | 2004 |
| Kept off the family tree | K040283 | FDA’s K040283 is Biopad Our reading of the summary gave K040283, FDA’s number for Biopad (Euroresearch Srl). Its FDA name has none of the distinctive words the summary uses for the device it names, “ViTelCare Turtle 800 Patient Monitoring System”. Kept off the family tree. Summary page 1…ViTelCareTM Patient Monitoring System (K04058 1) ViTelCareTM Turtle 800 Patient Monitoring System (C040283) ViTel Care TM Turtle 400 Patient Monitoring System (K043368) Manufa… | 2005 |
| * | K043368 | Vitelcare Turtle, Model 400Summary page 1…Monitoring System (C040283) ViTel Care TM Turtle 400 Patient Monitoring System (K043368) Manufactured By: ViTel Net 221 Elizabeth Street Utica,… | 2005 |
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 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- 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?
ViTelCare™ C-Turtle 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 MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient…
Read the full statement (111 words)
ViTelCare™ C-Turtle 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 MedVizer™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060712 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060712: Vitelcare C-Turtle Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060712
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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