Cleared Special

K210560 - Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210560 · Philips Medical Systems · Cardiovascular device
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Jun 2021
Decision
125d
Days
Class 2
Risk

K210560 is an FDA 510(k) clearance for the Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 .... Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Philips Medical Systems (Shanghai, CN). The FDA issued a Cleared decision on June 30, 2021 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Medical Systems devices

Submission Details

510(k) Number K210560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2021
Decision Date June 30, 2021
Days to Decision 125 days
Submission Type Special
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
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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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