510(k) · Cleared
ClearedModular Telemetry System for the Vision Telepak, Model 20701
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Research, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Jan 10, 2005 as substantially equivalent to K970763 (Medical Data Electronics, 1997) after a 35-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 10, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970763 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970763 Modular Telemetry System (MTS) Option for the Mde Escort II MonitorMedical Data Electronics · 1997
- This deviceK043354 Modular Telemetry System for the Vision Telepak, Model 20701Invivo Research, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II Monitor | Medical Data Electronics | 1997 | — |
| 0 (this device) | K043354 | Modular Telemetry System for the Vision Telepak, Model 20701 | Invivo Research, Inc. | 2005 | — |
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? (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 |
|---|---|---|---|
| * | K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II MonitorSummary page 1…anel: Division of Cardiovascular Product Code: 74DRT and 74DOA Predicate Device: MTS Option for the Escort II Monitor, K970763 Device Description: The Vision Telepak Telemetry Transmitter unit is a portable, wireless, patient monitor intended to be used… | 1997 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K970763.
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.
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 Vision Telepakt M Telemetry Transmitter is portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043354: Modular Telemetry System for the Vision Telepak, Model 20701.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043354
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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