510(k) Report

510(k) · Cleared

Cleared

Disposable Ecg Monitoring Electrode #4535 32X45MM

K950470510(k) TraditionalCleared Nov 6, 1995276-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

Nikomed U.S.A., Inc. · DRX Electrode, Electrocardiograph

Cleared on Nov 6, 1995 after a 276-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
Nov 6, 1995
Review
276 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 1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950470 Disposable Ecg Monitoring Electrode #4535 32X45MMNikomed U.S.A., Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK990111 Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570Maersk Medical A/S · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K990111Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570Maersk Medical A/S · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950470Disposable Ecg Monitoring Electrode #4535 32X45MMNikomed U.S.A., Inc.1995—
+1K990111Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570Maersk Medical A/S1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K950470, 1995–1999Source: 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
K990111Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570Maersk Medical A/S19990

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, K990111 (Maersk Medical A/S, 1999) 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 Nikomed U.S.A., Inc.

15 FDA decisions under this applicant name. See the company

  • K022909Nikomed Trace 1 Ecg ElectrodesNikomed U.S.A., Inc. · 2003
  • K000079Nikopad Electrosurgical Grounding Pad, Model 4777MNikomed U.S.A., Inc. · 20002 recalls
  • K950473Disposable Ecg Monitoring ElectrodeNikomed U.S.A., Inc. · 1995
  • K950472Disposable Ecg Monitoring Electrode #4110 45MM, #4140 35MMNikomed U.S.A., Inc. · 1995
  • K950475Disposable Ecg Monitoring Electrode #4530, #4540Nikomed U.S.A., Inc. · 1995

Recent decisions in DRX

The DRX category page

  • K171244PhysiotraceNimbleheart, Inc. · 2017
  • 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/K950470 · printed Nov 5, 2026

Cite this page

510(k) Report. “K950470: Disposable Ecg Monitoring Electrode #4535 32X45MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950470

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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