Cleared Traditional

K241890 - Philips Holter Analysis System

K241890 is an FDA 510(k) clearance for Philips Holter Analysis System, manufactured by Philips Medizin Systeme B?blingen GmbH. The device is a Class 2 Cardiovascular device with product code MLO cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K241890 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
266d
Days
Class 2
Risk

K241890 is an FDA 510(k) clearance for the Philips Holter Analysis System. Classified as Electrocardiograph, Ambulatory, With Analysis Algorithm (product code MLO), Class II - Special Controls.

Submitted by Philips Medizin Systeme B?blingen GmbH (Böblingen, DE). The FDA issued a Cleared decision on March 21, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medizin Systeme B?blingen GmbH devices

FDA 510(k) Submission Details - K241890

510(k) Number K241890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2024
Decision Date March 21, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLO Device Classification - Class 2, Special Controls

Product Code MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

All 7
Devices cleared under the same product code (MLO) and FDA review panel - the closest regulatory comparables to K241890.
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