510(k) · Cleared
ClearedCardiobeeper CB250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merdian Medical Technologies, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Nov 13, 1998 as substantially equivalent to K883843 (Survival Technology, Inc., 1988) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Nov 13, 1998
- Review
- 31 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K813101 (1981). 5 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 | K813101 | Cardiobeeper Memory Monitor | Survival Technology, Inc. | 1981 | — |
| −1 | K965101 | Cardiobeeper CB-12L | Meridian Medical Technologies, Inc. | 1997 | 1 |
| 0 (this device) | K983582 | Cardiobeeper CB250 | Merdian Medical Technologies, Ltd. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 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 |
|---|---|---|---|
| * | K883843 | Cardiobeeper IISummary page 2…nsmitting ECG information from a remote location to a receiving center. Specifically, the CardioBeeper ® CB250 is used in a similar manner to the CardioBeeper ® CBlII (K883843), and it shares some, but not all, of the functions of the CardioBeeper ® CB | (K883843) and the CardioBeeper ® CB12-L (K965101).… | 1988 |
| * | K965101 | Cardiobeeper CB-12LSummary page 2…milar manner to the CardioBeeper ® CBlII (K883843), and it shares some, but not all, of the functions of the CardioBeeper ® CB | (K883843) and the CardioBeeper ® CB12-L (K965101). The CardioBeeper ® CB250 is substantially equivalent to a CardioBeeper® CBIl (K883843) in Mode 1 (modified single channel). Bo… | 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
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 CardioBeeper CB250 is indicated for use by the patient in transmitting ECG information from a remote location to a receiving center.
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/K983582 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983582: Cardiobeeper CB250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983582
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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