510(k) · Cleared
ClearedDisposable Monitoring Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Intco Electrode Manufacturing Co., Ltd. · DRX Electrode, Electrocardiograph
Cleared on Sep 15, 2004 as substantially equivalent to K832877 (Advance Tech Intl., 1983) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Sep 15, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832877 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832877 Pre-Gelled Dispos ElectrodeAdvance Tech Intl. · 1983
- This deviceK041954 Disposable Monitoring ElectrodesShanghai Intco Electrode Manufacturing Co., Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832877 | Pre-Gelled Dispos Electrode | Advance Tech Intl. | 1983 | — |
| 0 (this device) | K041954 | Disposable Monitoring Electrodes | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 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 |
|---|---|---|---|
| * | K832877 | Pre-Gelled Dispos ElectrodeSummary page 1…odes Common/Usual Name: Monitoring Electrodes Classification Name: Electrodes, cutaneous Predicate devices: Lead-Lok Inc. K832877, K911518/D Device Description: These Monitoring Electrodes are non-sterile, hypoallergenic, disposable, adhesive-backed w… | 1983 |
| * | K911518 | Bunny Electrode/Stealth Solid Gel-Snap on FoamSummary page 1…Common/Usual Name: Monitoring Electrodes Classification Name: Electrodes, cutaneous Predicate devices: Lead-Lok Inc. K832877, K911518/D Device Description: These Monitoring Electrodes are non-sterile, hypoallergenic, disposable, adhesive-backed with condu… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
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?
These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of either wet gel or solid hydrogel can be used for better results. These electrodes can be used for short-term or long-term use. This product is disposable and should only be used for single applications, up to 3 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041954: Disposable Monitoring Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041954
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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