510(k) · Cleared
ClearedBT3/6, BT12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corscience GmbH & Co. KG · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Sep 2, 2008 as substantially equivalent to K052556 (Card Guard Scientific Survival, Ltd., 2006) after a 41-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it.
- Decided
- Sep 2, 2008
- Review
- 41 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942704 (1994). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK942704 Card Guard, Model CG-7000D Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1994
- 2 generations backK993799 CG-7000DX Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 1999
- 1 generation backK052556 CG-7000DX-BT Ecg Recorder/TransmitterCard Guard Scientific Survival, Ltd. · 2006
- This deviceK082077 BT3/6, BT12Corscience GmbH & Co. KG · 2008
- Descendant · cites it directly · 2 of its ownK110065 Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK150564 Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC · 2015
- Descendant · cites it directly · 1 of its ownK100813 QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS…Pulse Biomedical, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK163607 ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110065Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC · 2011 · cites it directly2descendants
- K150564Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC · 2015 · 2 generations on1descendant
- K100813QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbPulse Biomedical, Inc. · 2010 · cites it directly1descendant
- K163607ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd. · 2017 · 3 generations on0descendants
- K142352CardiacLinxRoss Medical Technology, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942704 | Card Guard, Model CG-7000D Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1994 | — |
| −2 | K993799 | CG-7000DX Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 1999 | — |
| −1 | K052556 | CG-7000DX-BT Ecg Recorder/Transmitter | Card Guard Scientific Survival, Ltd. | 2006 | — |
| 0 (this device) | K082077 | BT3/6, BT12 | Corscience GmbH & Co. KG | 2008 | — |
| +1 | K110065 | Spaulding IQ Electrocardiograph | Spaulding Clinical Research, LLC | 2011 | — |
| +2 | K150564 | Spaulding Electrocardiograph 2100iQ | Spaulding Clinical Research, LLC | 2015 | — |
| +1 | K100813 | QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb | Pulse Biomedical, Inc. | 2010 | — |
| +3 | K163607 | ECG Acquisition Systems | Vales & Hills Biomedical Tech., Ltd. | 2017 | — |
| +2 | K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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? (1)
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 |
|---|---|---|---|
| * | K052556 | CG-7000DX-BT Ecg Recorder/TransmitterSummary page 2…edicate Device Description 5.8.1 Name CG-7000DX-BT 5.8.2 Predicate Device Company Card Guard Scientific Survival, LTD. 5.8.3 Predicate Device 51O(k)# K052556 Document Name BT 510O(k).doc Isse I11.… | 2006 |
What descends from it? (6)
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)
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 14 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110065 (Spaulding Clinical Research, LLC, 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K052556.
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. 2008, this device’s year, is highlighted.
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 BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. The…
Read the full statement (182 words)
The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. The collected data is processed by the BT device and then transmitted via a standard wireless link to a monitoring device, such as a PC or hand-held device for display, review, printing, saving and post event processing by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.).
Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. The BT devices are not intended for monitoring critical patients and are not intended for intracardial use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082077: BT3/6, BT12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082077
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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