510(k) · Cleared
ClearedEms Telemedicine Option (for Gems Series 4000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Devices · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jan 18, 2002 as substantially equivalent to K896153 (General Devices, 1990) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jan 18, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K896153 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK896153 Modified DR-2C/PMC 100General Devices · 1990
- This deviceK013533 Ems Telemedicine Option (for Gems Series 4000)General Devices · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896153 | Modified DR-2C/PMC 100 | General Devices | 1990 | — |
| 0 (this device) | K013533 | Ems Telemedicine Option (for Gems Series 4000) | General Devices | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 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? (2)
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 |
|---|---|---|---|
| * | K896153 | Modified DR-2C/PMC 100Summary page 1…ommon Name: Manufacturer Classification: 510(k) No. GEMS Series 2000 (Modified DR-2C/PMC 100) EMS Communications Console General Devices (same as applicant) Class I K896153 Rosetta-Rx Demodulator, Data Translator General Devices (same as applicant) Class I K 002089 Page 1 of 4 KOi1… | 1990 |
| * | K002089 | Rosetta-LT/Rosetta-RXSummary page 1…EMS Communications Console General Devices (same as applicant) Class I K896153 Rosetta-Rx Demodulator, Data Translator General Devices (same as applicant) Class I K 002089 Page 1 of 4 KOi13537% 92/4‘ DESCRIPTION OF DEVICE The EMS Telemedicine Option is an optional element of the GE… | 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?
- None of the 2 ancestors has a recall.
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 ECG Telemedicine Option for the GEMS Series 4000 Communications Console is indicated for use when it is desired to communicate with distant medical devices in an EMS pre-hospital setting and to acquire and present information, such as single/12-lead ECG and physiologic/non-physiologic data, or other physiologic information which has been gathered by these devices.
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/K013533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013533: Ems Telemedicine Option (for Gems Series 4000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013533
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026