510(k) Report

510(k) · Cleared

Cleared

Conmed 2710 Cleartrace 2 LT Monitoring Ecg Electrode

K954388510(k) TraditionalCleared Feb 6, 1996140-day reviewClass II21 CFR 870.2360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Conmedcorp · DRX Electrode, Electrocardiograph

Cleared on Feb 6, 1996 after a 140-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Feb 6, 1996
Review
140 days
Class
Class II
Product code
DRX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954388 Conmed 2710 Cleartrace 2 LT Monitoring Ecg ElectrodeConmedcorp · 1996
  2. Descendant · cites it directly · 0 of its ownK091856 Conmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500)…Conmed Corporation · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K091856Conmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700, 2710, 1800…Conmed Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954388Conmed 2710 Cleartrace 2 LT Monitoring Ecg ElectrodeConmedcorp1996—
+1K091856Conmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700…Conmed Corporation2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K954388, 1996–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091856Conmed Ecg Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700, 2710, 1800…Conmed Corporation20090

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, K091856 (Conmed Corporation, 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DRX devices

DRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRX

1in 2017

2007: 32008: 32009: 72010: 52013: 12014: 12017: 1
2007high 7 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRX

78in 2010

2007: 147 days median2008: 17 days median2009: 89 days median2010: 78 days median
2007high 147 (2007) · low 17 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRX

6in 2022

2010: 42015: 12020: 52021: 12022: 6
2007high 6 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRX

250in 2025

2007: 472008: 152009: 362010: 482011: 802012: 412013: 702014: 272015: 582016: 372017: 552018: 432019: 502020: 532021: 552022: 612023: 1132024: 612025: 250
2007high 250 (2025) · low 15 (2008)2025

MAUDE reports naming product code DRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073147047
2008317015
2009789036
2010578448
20110—080
20120—041
20131—070
20141—027
20150—158
20160—037
20171—055
20180—043
20190—050
20200—553
20210—155
20220—661
20230—0113
20240—061
20250—0250
20260—0—

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https://510kreport.com/device/K954388 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954388: Conmed 2710 Cleartrace 2 LT Monitoring Ecg Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954388

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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