510(k) Report

510(k) · Cleared

Cleared

Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570

K990111510(k) TraditionalCleared Dec 6, 1999327-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

Maersk Medical A/S · DRX Electrode, Electrocardiograph

Cleared on Dec 6, 1999 as substantially equivalent to K950470 (Nikomed U.S.A., Inc., 1995) and 1 other predicate after a 327-day review. Its family tree reaches back 1 generation to 1995.

Decided
Dec 6, 1999
Review
327 days
Class
Class II
Product code
DRX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K950470 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK950470 · Disposable Ecg Monitoring Electrode #4535 32X45MM · Nikomed U.S.A., Inc. · 1995199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K950470 · Disposable Ecg Monitoring Electrode #4535 32X45MM · Nikomed U.S.A., Inc. · 19950
  1. Root · 1 generation backK950470 Disposable Ecg Monitoring Electrode #4535 32X45MMNikomed U.S.A., Inc. · 1995
  2. This deviceK990111 Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570Maersk Medical A/S · 1999
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K990111, 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
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What was it cleared against? (2)

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
*K950470Disposable Ecg Monitoring Electrode #4535 32X45MM
Summary page 1
…G Monitoring Electrodes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode PREDICATE DEVICE Disposable ECG Monitoring Electrode Models 4535 (K950470) and 4570 (K950478); Nikomed USA, Inc. DEVICE DESCRIPTION Pregelled electrodes are of Ag/AgCl construction with a sensor elemen…
Nikomed U.S.A., Inc.1995—
*K950478Disposable Ecg Monitoring Electrode #4570 38X60MM
Summary page 1
…odes Common Name: ECG Electrode Classification Name: Electrocardiograph Electrode PREDICATE DEVICE Disposable ECG Monitoring Electrode Models 4535 (K950470) and 4570 (K950478); Nikomed USA, Inc. DEVICE DESCRIPTION Pregelled electrodes are of Ag/AgCl construction with a sensor element area be- tween 10…
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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 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?

Short-term (< 24 hrs) ECG monitoring of infants in operating room and emergency situations (Model 4570); short-term (< 24 hrs) ECG monitoring of infants and neonates in operating room and emergency situations (Model 4520); short-term (< 24 hrs) ECG monitoring of adults and infants under anesthesia (Model 4535).

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
  • K990112Disposable Ecg Monitoring Electrodes, Models 4060, 4610Maersk Medical A/S · 1999
  • K990115Disposable Ecg Monitoring Electrodes, Models, 4420, 4440Maersk 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/K990111 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990111: Disposable Ecg Monitoring Electrodes, Models 4520, 4535, 4570.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990111

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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