510(k) · Cleared
ClearedPaljet-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Golden Gate Bio-Device · DRX Electrode, Electrocardiograph
Cleared on Feb 10, 1998 after a 138-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Feb 10, 1998
- Review
- 138 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK973663 Paljet-BGolden Gate Bio-Device · 1998
- Descendant · cites it directly · 22 of its ownK982470 Ecg Electrodes ApronTapuz Medical Technology, Ltd. · 1998
- Descendant · 2 generations on · 21 of its ownK043361 Accuheart Electrode BeltAdvanced Bioelectric Corporation · 2005
- Descendant · 3 generations on · 18 of its ownK063044 Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007
- Descendant · 4 generations on · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 5 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K982470Ecg Electrodes ApronTapuz Medical Technology, Ltd. · 1998 · cites it directly22descendants
- K043361Accuheart Electrode BeltAdvanced Bioelectric Corporation · 2005 · 2 generations on21descendants
- K063044Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007 · 3 generations on18descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · 4 generations on14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973663 | Paljet-B | Golden Gate Bio-Device | 1998 | — |
| +1 | K982470 | Ecg Electrodes Apron | Tapuz Medical Technology, Ltd. | 1998 | — |
| +2 | K043361 | Accuheart Electrode Belt | Advanced Bioelectric Corporation | 2005 | — |
| +3 | K063044 | Cardiobelt Electrode Belt | Monebo Technologies, Inc. | 2007 | — |
| +4 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +5 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | WaveTracer Named without a submission number |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982470 | Ecg Electrodes Apron | 1998 | 22 |
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, K982470 (Tapuz Medical Technology, Ltd., 1998) has gone furthest, with 22 descendants of its own.
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 Paljet-B patient cable system is a reusable ECG suction electrode system. It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market.
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/K973663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973663: Paljet-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973663
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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