Cleared Traditional

K241556 - Cardiac Workstation (5000)

Also marketed or referenced as:
Cardiac Workstation (7000)

K241556 is an FDA 510(k) clearance for Cardiac Workstation (5000), manufactured by Philips Medizin Systeme B?blingen GmbH. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K241556 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
200d
Days
Class 2
Risk

K241556 is an FDA 510(k) clearance for the Cardiac Workstation (5000). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Philips Medizin Systeme B?blingen GmbH (Boblingen, DE). The FDA issued a Cleared decision on December 17, 2024 after a review of 200 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 - K241556

510(k) Number K241556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2024
Decision Date December 17, 2024
Days to Decision 200 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
75d slower than avg
Panel avg: 125d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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.

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All 279
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