510(k) · Cleared
ClearedConmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700, 2710, 1800, Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · DRX Electrode, Electrocardiograph
Cleared on Aug 7, 2009 as substantially equivalent to K954388 (Conmedcorp, 1996) and 4 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 7, 2009
- Review
- 45 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K944849 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944849 2700 Cleartrace Radiotranslucent Monitoring Ecg ElectrobeConmed Andover Medical, Inc. · 1994
- This deviceK091856 Conmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500)…Conmed Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944849 | 2700 Cleartrace Radiotranslucent Monitoring Ecg Electrobe | Conmed Andover Medical, Inc. | 1994 | — |
| 0 (this device) | K091856 | Conmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700… | Conmed Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 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? (5)
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 |
|---|---|---|---|
| * | K954388 | Conmed 2710 Cleartrace 2 LT Monitoring Ecg ElectrodeSummary page 2…rdiovascular D. Predicate Devices ConMed 2710 CLEARTRACE 2LT Monitoring ECG Electrode ConMed Corporation 510(k) # K954388 2700 Cleartrace Radiotranslucent Monitoring ECG Electrode ConMed Andover Medical, Inc 510… | 1996 |
| * | K944849 | 2700 Cleartrace Radiotranslucent Monitoring Ecg ElectrobeSummary page 2…tion 510(k) # K954388 2700 Cleartrace Radiotranslucent Monitoring ECG Electrode ConMed Andover Medical, Inc 510(k) # K944849 ECG Electrode ConMed Andover Medical, Inc 510(k) # K944655 1800 Monitoring… | 1994 |
| * | K944655 | Ecg ElectrodeSummary page 2…ectrode ConMed Andover Medical, Inc 510(k) # K944849 ECG Electrode ConMed Andover Medical, Inc 510(k) # K944655 1800 Monitoring ECG Electrode And 1870 Diaphoretic Monitoring ECG Electrodes ConMed Andov… | 1994 |
| * | K945836 | 1800 Monitoring Ecg Electrode and 1870 Diaphoretic Monitoring Ecg ElectrodesSummary page 2…55 1800 Monitoring ECG Electrode And 1870 Diaphoretic Monitoring ECG Electrodes ConMed Andover Medical, Inc 510(k) # K945836 1700 Monitoring ECG Electrode ConMed Andover Medical, Inc 510(k) # K946273 === Page 3 ==… | 1995 |
| * | K946273 | 1700 Monitoring Ecg ElectrodeSummary page 2…ConMed Andover Medical, Inc 510(k) # K945836 1700 Monitoring ECG Electrode ConMed Andover Medical, Inc 510(k) # K946273 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1995 |
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 5 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. 2009, 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 ConMed ECG Monitoring Electrodes are pre-gelled, single patient use, disposable electrocardiographic electrodes for use as an accessory to ECG equipment for long term or short term monitoring and diagnostic procedures with regular or diaphoretic adhesives.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091856 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091856: Conmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700, 2710, 1800, Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091856
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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