510(k) Report

510(k) · Cleared

Cleared

1800 Monitoring Ecg Electrode and 1870 Diaphoretic Monitoring Ecg Electrodes

K945836510(k) TraditionalCleared Jun 20, 1995203-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

Conmed Andover Medical, Inc. · DRX Electrode, Electrocardiograph

Cleared on Jun 20, 1995 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jun 20, 1995
Review
203 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 deviceK945836 1800 Monitoring Ecg Electrode and 1870 Diaphoretic Monitoring Ecg…Conmed Andover Medical, Inc. · 1995
  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)K9458361800 Monitoring Ecg Electrode and 1870 Diaphoretic Monitoring Ecg ElectrodesConmed Andover Medical, Inc.1995—
+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 K945836, 1995–2009Source: 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 has not posted a summary or statement for it, 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—

More from Conmed Andover Medical, Inc.

8 FDA decisions under this applicant name. See the company

  • K9462731700 Monitoring Ecg ElectrodeConmed Andover Medical, Inc. · 1995
  • K944655Ecg ElectrodeConmed Andover Medical, Inc. · 1994
  • K9447261710 Monitoring Ecg ElectrodeConmed Andover Medical, Inc. · 1994
  • K9448492700 Cleartrace Radiotranslucent Monitoring Ecg ElectrobeConmed Andover Medical, Inc. · 1994
  • K942718Cloth Tens/Bnes ElectrodeConmed Andover Medical, Inc. · 1994

Recent decisions in DRX

The DRX category page

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  • K140096Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeHmicro, Inc. · 2014
  • K123658Biomodule 3-M1Zephyr Technology Corporation · 2013
  • K101576Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg ElectrodesTeam Innovations, Inc. · 2010
  • K101685IP-SETIntegral Process Sas · 20106 recalls

https://510kreport.com/device/K945836 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945836: 1800 Monitoring Ecg Electrode and 1870 Diaphoretic Monitoring Ecg Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945836

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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