510(k) · Cleared
Recalled · Class II · 2013Cardiobeeper CB-12L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Medical Technologies, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Mar 17, 1997 as substantially equivalent to K813101 (Survival Technology, Inc., 1981) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1981. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 17, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- DXH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K813101 (1981). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK813101 Cardiobeeper Memory MonitorSurvival Technology, Inc. · 1981
- This deviceK965101 Cardiobeeper CB-12LMeridian Medical Technologies, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK031229 Telzuit Cardiac Monitoring SystemTelzuit Technologies, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK983582 Cardiobeeper CB250Merdian Medical Technologies, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK980144 Heartview P12/8 Electrocardiograph Recorder and TransmitterAerotel, Ltd. · 1998
Most influential descendants
Showing 3 of 3 · See all- K031229Telzuit Cardiac Monitoring SystemTelzuit Technologies, Inc. · 2003 · cites it directly0descendants
- K983582Cardiobeeper CB250Merdian Medical Technologies, Ltd. · 1998 · cites it directly0descendants
- K980144Heartview P12/8 Electrocardiograph Recorder and TransmitterAerotel, Ltd. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813101 | Cardiobeeper Memory Monitor | Survival Technology, Inc. | 1981 | — |
| 0 (this device) | K965101 | Cardiobeeper CB-12L | Meridian Medical Technologies, Inc. | 1997 | — |
| +1 | K031229 | Telzuit Cardiac Monitoring System | Telzuit Technologies, Inc. | 2003 | — |
| +1 | K983582 | Cardiobeeper CB250 | Merdian Medical Technologies, Ltd. | 1998 | — |
| +1 | K980144 | Heartview P12/8 Electrocardiograph Recorder and Transmitter | Aerotel, Ltd. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K813101 | Cardiobeeper Memory MonitorSummary page 2…eiving center. Specifically, the rhythm strip operation of the CB-12L is substantially equivalent to the single-lead operation of the CardioBeeper® CB300 Memory Monitor (K813101), and the 12 lead operation of the CB-12L is substantially equivalent to the multiple-lead operation of the Card Guard 9000 (K924… | 1981 |
| * | K924486 | Card Guard, Model CG-9000Summary page 2…CardioBeeper® CB300 Memory Monitor (K813101), and the 12 lead operation of the CB-12L is substantially equivalent to the multiple-lead operation of the Card Guard 9000 (K924486) and the Aerotel Heartview (K950004). A clinical study was conducted with a study population of 97 patients in order to: (1) com… | 1994 |
| * | K950004 | Heartview (TM) 12-Lead Electrocardiograph Recorder/TransmitterSummary page 2…(K813101), and the 12 lead operation of the CB-12L is substantially equivalent to the multiple-lead operation of the Card Guard 9000 (K924486) and the Aerotel Heartview (K950004). A clinical study was conducted with a study population of 97 patients in order to: (1) compare the diagnostic quality of 12 le… | 1995 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2013 | Class II | Z-1011-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K031229 (Telzuit Technologies, Inc., 2003) has gone furthest, with 0 descendants of its own.
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 CardicBeeper® CB-12L is intended to condition an electrocardiograph signal so that it can be transmitted via a telephone line to a remote location. The CB-12L is designed to be used by a patient to transmit a rhythm strip or a 12 lead ECG signal in real time to a physician’s office, hospital or other medical receiving center. Note that due to the discrete options for selecting the precordial electrode positions, the CB-12L transmission may only approximate a standard 12 lcad ECG for some patients.
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/K965101 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965101: Cardiobeeper CB-12L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965101
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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