510(k) · Cleared
ClearedCardiobeeper CB12/12, Model CB12/12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Medical Technologies, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Oct 25, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Oct 25, 2000
- Review
- 86 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK002310 Cardiobeeper CB12/12, Model CB12/12Meridian Medical Technologies, Ltd. · 2000
- Descendant · cites it directly · 11 of its ownK080047 Cardiosen'cShl Telemedicine International, Ltd. · 2008
- Descendant · 2 generations on · 10 of its ownK113514 SmartheartShl Telemedicine International, Ltd. · 2012
- Descendant · 3 generations on · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · 4 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 5 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K080047Cardiosen'cShl Telemedicine International, Ltd. · 2008 · cites it directly11descendants
- K113514SmartheartShl Telemedicine International, Ltd. · 2012 · 2 generations on10descendants
- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · 3 generations on6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 4 generations on5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002310 | Cardiobeeper CB12/12, Model CB12/12 | Meridian Medical Technologies, Ltd. | 2000 | — |
| +1 | K080047 | Cardiosen'c | Shl Telemedicine International, Ltd. | 2008 | — |
| +2 | K113514 | Smartheart | Shl Telemedicine International, Ltd. | 2012 | — |
| +3 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +4 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +5 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080047 | Cardiosen'c | 2008 | 11 |
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?
- Of its descendants, K080047 (Shl Telemedicine International, Ltd., 2008) has gone furthest, with 11 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 | — |
https://510kreport.com/device/K002310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002310: Cardiobeeper CB12/12, Model CB12/12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002310
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026