510(k) · Cleared
ClearedPhilips Holter Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Böblingen GmbH · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Mar 21, 2025 as substantially equivalent to K010949 (Agilent Technologies, 2001) after a 266-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 21, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930806 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 3 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 2 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 1 generation backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- This deviceK241890 Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −3 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −2 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −1 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| 0 (this device) | K241890 | Philips Holter Analysis System | Philips Medizin Systeme Böblingen GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 MLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010949 | 2010 Plus Holter for WindowsSummary page 5…510(k) No. Device Name Code Predicate Device K010949 2010 Plus Holter for Windows MLO The Philips Holter Analysis System is substantially equivalent to the… | 2001 |
| † | K071733 | DL900 Series Holter Recorder | 2007 |
| † | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | 2010 |
| † | K020456 | Easi 12 Lead Algorithm | 2002 |
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?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K010949.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of: • Symptoms that may be related to rhythm disturbances of the heart in adult patients • Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this…
Read the full statement (205 words)
The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of:
• Symptoms that may be related to rhythm disturbances of the heart in adult patients
• Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional.
• Efficacy of antiarrhythmic therapy
• Pacemaker function
• Symptoms that may be associated with myocardial ischemia
The Philips Holter Analysis System is not intended for use for pediatric patients.
The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters:
• Age: Between 33 to 82 years
• Height: Between 147 to 185 cm (58 to 73 inches)
• Weight: Between 53 to 118 kg (117 to 261 lbs)
• Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)
If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241890: Philips Holter Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241890
Report an extraction error
Are you the manufacturer?
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