510(k) · Cleared
ClearedEventstation Ecg Trans-Telephonic Receiving System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reynolds Medical, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 8, 1999 as substantially equivalent to K972649 (Reynolds Medical, Ltd., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jul 8, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923930 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| −1 | K972649 | Cardiocall Cardiac Event Recorder | Reynolds Medical, Ltd. | 1997 | 1 |
| 0 (this device) | K991211 | Eventstation Ecg Trans-Telephonic Receiving System | Reynolds Medical, Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 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 |
|---|---|---|---|
| * | K972649 | Cardiocall Cardiac Event RecorderSummary page 1…nic system. Classification name: Transmitters and Receivers, Electrocardiograph, Telephone, 74 DXH (3) Equivalent legally-marketed devices. 1. Reynolds Cardio-Connect, K972649 2. Paceart Cardio-Voice, K952065. (4) Description Reynolds EventStation 510(k) Submission Page A 5 The EventSta… | 1997 |
| * | K952065 | Paceart CardiovoiceSummary page 1…Transmitters and Receivers, Electrocardiograph, Telephone, 74 DXH (3) Equivalent legally-marketed devices. 1. Reynolds Cardio-Connect, K972649 2. Paceart Cardio-Voice, K952065. (4) Description Reynolds EventStation 510(k) Submission Page A 5 The EventStation enables the physician to rec… | 1996 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K972649.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic “Unattended Mode” or a manual “Attended Mode.” It has no ECG analysis capability, and is not intended to be used for this purpose. The system can also download the contents of Reynolds event recorders directly by means of a cable. It is not intended to display pacemaker activity.
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/K991211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991211: Eventstation Ecg Trans-Telephonic Receiving System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991211
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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