510(k) · Cleared
ClearedAccuheart Electrode Belt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Bioelectric Corporation · DRX Electrode, Electrocardiograph
Cleared on Mar 22, 2005 as substantially equivalent to K960968 (Graphic Controls Corp., 1996) and 1 other predicate after a 105-day review. Its family tree reaches back 2 generations to 1986. 21 later devices descend from it.
- Decided
- Mar 22, 2005
- Review
- 105 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K863116 (1986). 5 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK863116 Cardiofax Ecg-6551 (Electrocardiogrph)Nihon Kohden America, Inc. · 1986
- 1 generation backK982470 Ecg Electrodes ApronTapuz Medical Technology, Ltd. · 1998
- This deviceK043361 Accuheart Electrode BeltAdvanced Bioelectric Corporation · 2005
- Descendant · cites it directly · 18 of its ownK063044 Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007
- Descendant · 2 generations on · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 3 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · 3 generations on · 10 of its ownK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- Descendant · 4 generations on · 9 of its ownK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K063044Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007 · cites it directly18descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · 2 generations on14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 3 generations on13descendants
- K121617SensicardiacDiacoustic Medical (Pty) · 2012 · 3 generations on10descendants
- K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863116 | Cardiofax Ecg-6551 (Electrocardiogrph) | Nihon Kohden America, Inc. | 1986 | — |
| −1 | K982470 | Ecg Electrodes Apron | Tapuz Medical Technology, Ltd. | 1998 | — |
| 0 (this device) | K043361 | Accuheart Electrode Belt | Advanced Bioelectric Corporation | 2005 | — |
| +1 | K063044 | Cardiobelt Electrode Belt | Monebo Technologies, Inc. | 2007 | — |
| +2 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +3 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +3 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| +4 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K960968 | Medi-Trace 200, Medi-Trace 200-30Summary page 1…Devices to Which Substantial Equivalence is Claimed: Device Name: Medi-Trace 200 and Medi-Trace 200-30 ECG Electrodes 510(k) Number: K960968 Device Name: ECG Electrodes Apron 5 10(k) Number: K982470 Device Description: The AccnHeart'm… | 1996 |
| * | K982470 | Ecg Electrodes ApronSummary page 1…ace 200 and Medi-Trace 200-30 ECG Electrodes 510(k) Number: K960968 Device Name: ECG Electrodes Apron 5 10(k) Number: K982470 Device Description: The AccnHeart'm Electrode Belt is a reusable electrode system consisting of an electrode assembly, an elasti… | 1998 |
What descends from it? (21)
See all 213 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 19 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K063044 (Monebo Technologies, Inc., 2007) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K960968.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 AccuHeartTM Electrode Belt is a reusable electrode system intended for use in
general electrocardiograph procedures where ECG monitoring is deemed necessary and is
ordered by a physician. The AccuHeartTM Electrode Belt is compatible for use with most
ECG instruments on the market.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043361: Accuheart Electrode Belt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043361
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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