510(k) · Cleared
ClearedTelenable Ems System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molex, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 30, 2004 as substantially equivalent to K002089 (General Devices, 2000) after a 110-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 30, 2004
- Review
- 110 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002089 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002089 Rosetta-LT/Rosetta-RXGeneral Devices · 2000
- This deviceK040663 Telenable Ems SystemMolex, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002089 | Rosetta-LT/Rosetta-RX | General Devices | 2000 | — |
| 0 (this device) | K040663 | Telenable Ems System | Molex, Inc. | 2004 | — |
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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K002089 | Rosetta-LT/Rosetta-RXSummary page 1…ufacturer General Devices Classification: Class II 510(k) Nac K002089 1 1. 510(k) Summary of TelEnable EMS System 1.1. Des… | 2000 |
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.
- 1 other device also cites its predicate K002089.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The TelEnable EMS System provides a mechanism to transmit 12-lead ECGs from a portable ECG monitor to a central location such as a hospital. This system connects to the ECG via a standard POTS (Plain Old Telephone System) interface and communicates to the ECG via standard Group 3 facsimile (fax) protocol. All information received by the TelEnable EMS System's mobile component (EMS-Enable) is relayed wirelessly to a central receiving station (EMS Hub).…
Read the full statement (159 words)
The TelEnable EMS System provides a mechanism to transmit 12-lead ECGs from a portable ECG monitor to a central location such as a hospital. This system connects to the ECG via a standard POTS (Plain Old Telephone System) interface and communicates to the ECG via standard Group 3 facsimile (fax) protocol.
All information received by the TelEnable EMS System's mobile component (EMS-Enable) is relayed wirelessly to a central receiving station (EMS Hub). Such a station can be co-located in a hospital or at an EMS dispatch center.
The ECGs received may either be printed locally or forwarded, via fax, to the destination specified by the ECG operator.
No component of the TelEnable EMS System is connected directly to a patient. The TelEnable EMS System is non-invasive. The ECG monitor operator shall observe all the same precautions when connecting the ECG monitor to the EMS-Enable component as when connecting the ECG monitor directly to the PSTN (Public Switch Telephone Network).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040663: Telenable Ems System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040663
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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