510(k) Report

510(k) · Cleared

Cleared

Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X

K100129510(k) AbbreviatedCleared Jun 11, 2010143-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

Ambu A/S · DRX Electrode, Electrocardiograph

Cleared on Jun 11, 2010 as substantially equivalent to K902407 (Medicotest, Inc., 1990) and 3 other predicates after a 143-day review. Its family tree reaches back 1 generation to 1990.

Decided
Jun 11, 2010
Review
143 days
Class
Class II
Product code
DRX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K902407 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2002: 1 other ancestor1992: 1 other ancestorK902407 · NF-50-E Disposable Ecg Electrode · Medicotest, Inc. · 199019901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors K902407 · NF-50-E Disposable Ecg Electrode · Medicotest, Inc. · 19900
  1. Root · 1 generation backK902407 NF-50-E Disposable Ecg ElectrodeMedicotest, Inc. · 1990
  2. This deviceK100129 Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XAmbu A/S · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902407NF-50-E Disposable Ecg ElectrodeMedicotest, Inc.1990—
0 (this device)K100129Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XAmbu A/S2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
200210
200610
FIG. 1 — Lineage of K100129, 1990–2010Source: 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? (4)

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
*K902407NF-50-E Disposable Ecg Electrode
Summary page 1
…device to which equivalence is claimed Manufacturer Trade Name 510k number Product code Ambu A/S Ambu® Blue K(902407 DRX Sensor NF Ambu A/S Ambu® Blue K(921579…
Medicotest, Inc.1990—
*K921579BR-50-J Disposable Ecg Electrode
Summary page 1
…e Ambu A/S Ambu® Blue K(902407 DRX Sensor NF Ambu A/S Ambu® Blue K(921579 DRX Sensor BRS Neotech Prod- Micro NeoLead K(011564…
Medicotest, Inc.1992—
*K011564Neolead
Summary page 1
…Ambu A/S Ambu® Blue K(921579 DRX Sensor BRS Neotech Prod- Micro NeoLead K(011564 DRX ucts, Inc. Ambu A/S Ambu® Blue K(053550 DRX…
Neotech Products, Inc.2002—
*K053550Ambu Blue Sensor Neo and Neo X
Summary page 1
…Sensor BRS Neotech Prod- Micro NeoLead K(011564 DRX ucts, Inc. Ambu A/S Ambu® Blue K(053550 DRX Sensor NEO/NEO X…
Ambu A/S2006—

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 4 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. 2010, this device’s year, is highlighted.

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?

The Ambu® Blue Sensor PJEO and Ambu® Blue Sensor NEO X electrodes are made for EGG monitoring of neonatal and paediatric patients. The EGG electrodes are applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The electrodes are for single patient use only.

Indications for use as stated in the FDA summary.

More from Ambu A/S

41 FDA decisions under this applicant name. See the company

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  • K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2026
  • K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup…Ambu A/S · 2026
  • K251583Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026
  • K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)Ambu A/S · 2025

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/K100129 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100129: Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100129

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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