510(k) · Cleared
ClearedMeditrace Pellet Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graphic Controls Corp. · DRX Electrode, Electrocardiograph
Cleared on May 18, 1982 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 18, 1982
- Review
- 28 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK821137 Meditrace Pellet ElectrodeGraphic Controls Corp. · 1982
- Descendant · cites it directly · 6 of its ownK062198 Sunspots Pre-Gelled Surface ElectrodesAxon Systems, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK110289 Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK142159 Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK081871 Universal ElectrodesNeurometrix, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK172703 Disposable Snap ElectrodeEmbla Systems · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062198Sunspots Pre-Gelled Surface ElectrodesAxon Systems, Inc. · 2006 · cites it directly6descendants
- K110289Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011 · 2 generations on2descendants
- K142159Disposable Pre-Gelled Surface ElectrodeRochester Electro Medical, Inc. · 2015 · 3 generations on1descendant
- K081871Universal ElectrodesNeurometrix, Inc. · 2008 · 2 generations on1descendant
- K172703Disposable Snap ElectrodeEmbla Systems · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821137 | Meditrace Pellet Electrode | Graphic Controls Corp. | 1982 | — |
| +1 | K062198 | Sunspots Pre-Gelled Surface Electrodes | Axon Systems, Inc. | 2006 | — |
| +2 | K110289 | Friendship Medical Disposable Pre-Gelled AG / Agcl Surface Electrode | Xian Friendship Medical Electronics Co., Ltd. | 2011 | — |
| +3 | K142159 | Disposable Pre-Gelled Surface Electrode | Rochester Electro Medical, Inc. | 2015 | — |
| +2 | K081871 | Universal Electrodes | Neurometrix, Inc. | 2008 | — |
| +4 | K172703 | Disposable Snap Electrode | Embla Systems | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062198 | Sunspots Pre-Gelled Surface Electrodes | 2006 | 6 |
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, K062198 (Axon Systems, Inc., 2006) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K821137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K821137: Meditrace Pellet Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821137
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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