510(k) · Cleared
ClearedCardiobelt Electrode Belt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monebo Technologies, Inc. · DRX Electrode, Electrocardiograph
Cleared on Mar 23, 2007 as substantially equivalent to K043361 (Advanced Bioelectric Corporation, 2005) and 2 other predicates after a 170-day review. Its family tree reaches back 3 generations to 1986. 18 later devices descend from it.
- Decided
- Mar 23, 2007
- Review
- 170 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K863116 (1986). 9 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK863116 Cardiofax Ecg-6551 (Electrocardiogrph)Nihon Kohden America, Inc. · 1986
- 2 generations backK982470 Ecg Electrodes ApronTapuz Medical Technology, Ltd. · 1998
- 1 generation backK043361 Accuheart Electrode BeltAdvanced Bioelectric Corporation · 2005
- This deviceK063044 Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007
- Descendant · cites it directly · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 2 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · 2 generations on · 10 of its ownK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- Descendant · 3 generations on · 9 of its ownK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- Descendant · 4 generations on · 7 of its ownK181988 eMurmur IDCsd Labs GmbH · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · cites it directly14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 2 generations on13descendants
- K121617SensicardiacDiacoustic Medical (Pty) · 2012 · 2 generations on10descendants
- K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013 · 3 generations on9descendants
- K181988eMurmur IDCsd Labs GmbH · 2019 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863116 | Cardiofax Ecg-6551 (Electrocardiogrph) | Nihon Kohden America, Inc. | 1986 | — |
| −2 | K982470 | Ecg Electrodes Apron | Tapuz Medical Technology, Ltd. | 1998 | — |
| −1 | K043361 | Accuheart Electrode Belt | Advanced Bioelectric Corporation | 2005 | — |
| 0 (this device) | K063044 | Cardiobelt Electrode Belt | Monebo Technologies, Inc. | 2007 | — |
| +1 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +2 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +2 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| +3 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| +4 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 DRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K043361 | Accuheart Electrode BeltSummary page 1…ode: 74 DRX Devices to Which Substantial Equivalence is Claimed: Device Name: AccuHeartTm Electrode Belt 5 10(k) Number: K043361 Device Name: Medi-Trace 200 and Medi-Trace 200-30 ECG Electrodes 5 10(k) Number: K960968 Device Na… | 2005 |
| * | K960968 | Medi-Trace 200, Medi-Trace 200-30Summary page 1…rtTm Electrode Belt 5 10(k) Number: K043361 Device Name: Medi-Trace 200 and Medi-Trace 200-30 ECG Electrodes 5 10(k) Number: K960968 Device Name: CardGuard CG-2211 SelfChek 510(k) Number: K012223 Device Description: The Monebo C… | 1996 |
| * | K012223 | CG-2211 Selfcheck Ecg TransmitterSummary page 1…ace 200 and Medi-Trace 200-30 ECG Electrodes 5 10(k) Number: K960968 Device Name: CardGuard CG-2211 SelfChek 510(k) Number: K012223 Device Description: The Monebo CardioBeltTM is a reusable electrode system consisting of an electrode assembly, an elastic ches… | 2001 |
What descends from it? (18)
See all 182 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 21 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K083309 (Zargis Medical Corp., 2009) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K043361.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CardioBeltTM is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBeltTM is compatible for use with Bluetooth equipped ECG instruments capable of receiving BluetoothTM Serial Port Protocol.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063044: Cardiobelt Electrode Belt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063044
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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