510(k) Report

510(k) · Cleared

Recalled · 2010

Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560

K990113510(k) TraditionalCleared Dec 6, 1999327-day reviewClass II21 CFR 870.2360Recalls 1

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

Maersk Medical A/S · DRX Electrode, Electrocardiograph

Cleared on Dec 6, 1999 as substantially equivalent to K950473 (Nikomed U.S.A., Inc., 1995) and 4 other predicates after a 327-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.

Decided
Dec 6, 1999
Review
327 days
Class
Class II
Product code
DRX
Recalls
1
Predicates
5

Its longest line of descent runs back 1 generation to K950474 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 4 other ancestorsK950474 · Disposable Ecg Monitoring Electrode #4533 32X45MM · Nikomed U.S.A., Inc. · 1995199619982000
Other ancestors, by generation 1 generation back: 4 other ancestors K950474 · Disposable Ecg Monitoring Electrode #4533 32X45MM · Nikomed U.S.A., Inc. · 19950
  1. Root · 1 generation backK950474 Disposable Ecg Monitoring Electrode #4533 32X45MMNikomed U.S.A., Inc. · 1995
  2. This deviceK990113 Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539…Maersk Medical A/S · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950474Disposable Ecg Monitoring Electrode #4533 32X45MMNikomed U.S.A., Inc.1995—
0 (this device)K990113Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and…Maersk Medical A/S1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199540
FIG. 1 — Lineage of K990113, 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), 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K950473Disposable Ecg Monitoring Electrode
Summary page 1
…itoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode lll. PREDICATE DEVICES Disposable ECG Monitoring Electrode Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc. IV. DEVICE DESCRIPTION Pregelle…
Nikomed U.S.A., Inc.1995—
*K950475Disposable Ecg Monitoring Electrode #4530, #4540
Summary page 1
…Name: ECG Electrode Classification Name: Electrocardiograph Electrode lll. PREDICATE DEVICES Disposable ECG Monitoring Electrode Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc. IV. DEVICE DESCRIPTION Pregelled electrodes are of Ag/Ag…
Nikomed U.S.A., Inc.1995—
*K950474Disposable Ecg Monitoring Electrode #4533 32X45MM
Summary page 1
…rode Classification Name: Electrocardiograph Electrode lll. PREDICATE DEVICES Disposable ECG Monitoring Electrode Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc. IV. DEVICE DESCRIPTION Pregelled electrodes are of Ag/AgCl construction…
Nikomed U.S.A., Inc.1995—
*K950480Disposable Ecg Monitoring Electrode #4539 28X45MM
Summary page 1
…ion Name: Electrocardiograph Electrode lll. PREDICATE DEVICES Disposable ECG Monitoring Electrode Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc. IV. DEVICE DESCRIPTION Pregelled electrodes are of Ag/AgCl construction with a sensor el…
Nikomed U.S.A., Inc.1995—
*K950477Disposable Ecg Monitoring Electrode #4560 38X60MM
Summary page 1
…rdiograph Electrode lll. PREDICATE DEVICES Disposable ECG Monitoring Electrode Models 4500 (K950473), 4530 and 4540 (K950475), 4533 (K950474), 4539 (K950480) and 4560 (K950477); Nikomed USA, Inc. IV. DEVICE DESCRIPTION Pregelled electrodes are of Ag/AgCl construction with a sensor element area between…
Nikomed U.S.A., Inc.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)

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2010Not classifiedZ-1431-2010Process designIn an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.

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 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—

What is it indicated for?

ECG monitoring electrodes for short term use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Maersk Medical A/S

9 FDA decisions under this applicant name. See the company

  • K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 20011 Class I recall
  • K002138Paradigm Silhouette, Models MMT-377, 378, 379, 380Maersk Medical A/S · 20002 recalls
  • K990111Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570Maersk Medical A/S · 1999
  • K990112Disposable Ecg Monitoring Electrodes, Models 4060, 4610Maersk Medical A/S · 1999
  • K990110Disposable Ecg Monitoring Electrodes, Model 4110, 4140Maersk Medical A/S · 1999

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/K990113 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990113: Disposable Ecg Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990113

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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