# K241890: Philips Holter Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Böblingen GmbH
- Decided: Mar 21, 2025 after 266 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930806 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010949: 2010 Plus Holter for Windows, Agilent Technologies (2001) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K241890
Methodology: https://510kreport.com/methodology